Powered surgical instrument

ABSTRACT

A method of operating a surgical instrument is disclosed. The surgical instrument includes an electronic system comprising an electric motor coupled to the end effector; a motor controller coupled to the motor; a parameter threshold detection module configured to monitor multiple parameter thresholds; a sensing module configured to sense tissue compression; a processor coupled to the parameter threshold detection module and the motor controller; and a memory coupled to the processor. The memory stores executable instructions that when executed by the processor cause the processor to monitor multiple levels of action thresholds and monitor speed of the motor and increment a drive unit of the motor, sense tissue compression, and provide rate and control feedback to the user of the surgical instrument.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 14/640,746, entitledPOWERED SURGICAL INSTRUMENT, filed Mar. 6, 2015, now U.S. PatentApplication Publication No. 2016/0256184, the entire disclosure of whichis hereby incorporated by reference herein.

BACKGROUND

The present disclosure relates to surgical instruments and, in variouscircumstances, to surgical stapling and cutting instruments and staplecartridges therefor that are designed to staple and cut tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present disclosure, and the manner ofattaining them, will become more apparent and the present disclosurewill be better understood by reference to the following description ofthe present disclosure taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is a perspective view of a surgical instrument that has aninterchangeable shaft assembly operably coupled thereto;

FIG. 2 is an exploded assembly view of the interchangeable shaftassembly and surgical instrument of FIG. 1;

FIG. 3 is another exploded assembly view showing portions of theinterchangeable shaft assembly and surgical instrument of FIGS. 1 and 2;

FIG. 4 is an exploded assembly view of a portion of the surgicalinstrument of FIGS. 1-3;

FIG. 5 is a cross-sectional side view of a portion of the surgicalinstrument of FIG. 4 with the firing trigger in a fully actuatedposition;

FIG. 6 is another cross-sectional view of a portion of the surgicalinstrument of FIG. 5 with the firing trigger in an unactuated position;

FIG. 7 is an exploded assembly view of one form of an interchangeableshaft assembly;

FIG. 8 is another exploded assembly view of portions of theinterchangeable shaft assembly of FIG. 7;

FIG. 9 is another exploded assembly view of portions of theinterchangeable shaft assembly of FIGS. 7 and 8;

FIG. 10 is a cross-sectional view of a portion of the interchangeableshaft assembly of FIGS. 7-9;

FIG. 11 is a perspective view of a portion of the shaft assembly ofFIGS. 7-10 with the switch drum omitted for clarity;

FIG. 12 is another perspective view of the portion of theinterchangeable shaft assembly of FIG. 11 with the switch drum mountedthereon;

FIG. 13 is a perspective view of a portion of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anunactuated position;

FIG. 14 is a right side elevational view of the interchangeable shaftassembly and surgical instrument of FIG. 13;

FIG. 15 is a left side elevational view of the interchangeable shaftassembly and surgical instrument of FIGS. 13 and 14;

FIG. 16 is a perspective view of a portion of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anactuated position and a firing trigger thereof in an unactuatedposition;

FIG. 17 is a right side elevational view of the interchangeable shaftassembly and surgical instrument of FIG. 16;

FIG. 18 is a left side elevational view of the interchangeable shaftassembly and surgical instrument of FIGS. 16 and 17;

FIG. 18A is a right side elevational view of the interchangeable shaftassembly of FIG. 11 operably coupled to a portion of the surgicalinstrument of FIG. 1 illustrated with the closure trigger thereof in anactuated position and the firing trigger thereof in an actuatedposition;

FIG. 19 is a schematic of a system for powering down an electricalconnector of a surgical instrument handle when a shaft assembly is notcoupled thereto;

FIG. 20 is an exploded view of one aspect of an end effector of thesurgical instrument of FIG. 1;

FIGS. 21A-21B is a circuit diagram of the surgical instrument of FIG. 1spanning two drawings sheets;

FIG. 22 illustrates one instance of a power assembly comprising a usagecycle circuit configured to generate a usage cycle count of the batteryback;

FIG. 23 illustrates one aspect of a process for sequentially energizinga segmented circuit;

FIG. 24 illustrates one aspect of a power segment comprising a pluralityof daisy chained power converters;

FIG. 25 illustrates one aspect of a segmented circuit configured tomaximize power available for critical and/or power intense functions;

FIG. 26 illustrates one aspect of a power system comprising a pluralityof daisy chained power converters configured to be sequentiallyenergized;

FIG. 27 illustrates one aspect of a segmented circuit comprising anisolated control section;

FIG. 28, which is divided into FIGS. 28A and 28B, is a circuit diagramof the surgical instrument of FIG. 1;

FIG. 29 is a block diagram the surgical instrument of FIG. 1illustrating interfaces between the handle assembly 14 and the powerassembly and between the handle assembly 14 and the interchangeableshaft assembly;

FIG. 30 illustrates one aspect of a process for utilizing thresholds tomodify operations of a surgical instrument;

FIG. 31 illustrates an example graph showing modification of operationsof a surgical instrument describing a linear function;

FIG. 32 illustrates an example graph showing modification of operationsof a surgical instrument describing a non-linear function;

FIG. 33 illustrates an example graph showing modification of operationsof a surgical instrument based on an expected user input parameter;

FIG. 34 illustrates an example graph showing modification of velocity ofa drive based on detection of a threshold;

FIG. 35 illustrates an example graph showing modification in connectionwith operations based on battery current based on detection of athreshold;

FIG. 36 illustrates an example graph showing modification in connectionwith operations based on battery voltage based on detection of athreshold;

FIG. 37 illustrates an example graph showing modification of knife speedbased on detection of a cycle threshold;

FIG. 38 illustrates a logic diagram of a system for evaluating sharpnessof a cutting edge of a surgical instrument according to various aspects;

FIG. 39 illustrates a logic diagram of a system for determining theforces applied against a cutting edge of a surgical instrument by asharpness testing member at various sharpness levels according tovarious aspects;

FIG. 40 illustrates a flow chart of a method for determining whether acutting edge of a surgical instrument is sufficiently sharp to transecttissue captured by the surgical instrument according to various aspects;

FIG. 41 illustrates a chart of the forces applied against a cutting edgeof a surgical instrument by a sharpness testing member at varioussharpness levels according to various embodiments.

FIG. 42 illustrates a flow chart outlining a method for determiningwhether a cutting edge of a surgical instrument is sufficiently sharp totransect tissue captured by the surgical instrument according to variousembodiments.

FIG. 43 illustrates one aspect of a process for adapting operations of asurgical instrument;

FIG. 44 illustrates one aspect of a process for adapting operations of asurgical instrument;

FIG. 45 illustrates one aspect of a mechanism for adapting operations ofa surgical instrument in the context of closure motion and tissuepressure;

FIG. 46 illustrates one aspect of a mechanism for adapting speedassociated with a parameter of a surgical instrument in the context oftissue modification and sensor modification;

FIG. 47 illustrates one aspect of a mechanism for adapting firing rateassociated with a parameter of a surgical instrument in the context oftissue modification and sensor modification;

FIG. 48 illustrates one aspect of a mechanism for adapting operationsassociated with a surgical instrument in the context of tissuecompression during a clamping phase;

FIG. 49 illustrates one aspect of a mechanism for adapting operationsassociated with a surgical instrument in the context of tissuecompression during a firing phase;

FIG. 50 illustrates one aspect of a mechanism for adapting operationsassociated with a surgical instrument in the context of slowing a firingevent where a peak is predicted above a limit;

FIG. 51 illustrates a portion of tissue having a disparity in thickness;

FIG. 52 depicts an example medical device that can include one or moreaspects of the present disclosure;

FIG. 53A depicts an example end-effector of a medical device surroundingtissue in accordance with one or more aspects of the present disclosure;

FIG. 53B depicts an example end-effector of a medical device compressingtissue in accordance with one or more aspects of the present disclosure;

FIG. 54A depicts example forces exerted by an end-effector of a medicaldevice compressing tissue in accordance with one or more aspects of thepresent disclosure;

FIG. 54B also depicts example forces exerted by an end-effector of amedical device compressing tissue in accordance with one or more aspectsof the present disclosure;

FIG. 55 depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure;

FIG. 56 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure;

FIG. 57 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure;

FIG. 58 depicts an example end-effector channel frame in accordance withone or more aspects of the present disclosure;

FIG. 59 depicts an example end-effector in accordance with one or moreaspects of the present disclosure;

FIG. 60 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure;

FIG. 61 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure;

FIG. 62 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure;

FIG. 63 depicts an example electrode in accordance with one or moreaspects of the present disclosure;

FIG. 64 depicts an example electrode wiring system in accordance withone or more aspects of the present disclosure;

FIG. 65 also depicts an example end-effector channel frame in accordancewith one or more aspects of the present disclosure;

FIG. 66 is an example circuit diagram in accordance with one or moreaspects of the present disclosure;

FIG. 67 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure;

FIG. 68 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure;

FIG. 69 is graph depicting an example frequency modulation in accordancewith one or more aspects of the present disclosure;

FIG. 70 is graph depicting a compound RF signal in accordance with oneor more aspects of the present disclosure;

FIG. 71 is graph depicting filtered RF signals in accordance with one ormore aspects of the present disclosure;

FIG. 72 is a plan view of a speed sensor assembly for a surgicalinstrument power train;

FIG. 73 is a longitudinal cross section through plane A of FIG. 71;

FIG. 74 is a perspective view of a speed sensor assembly for a brushlessmotor;

FIG. 75 is a transverse cross section through plane B of FIG. 73;

FIG. 76 is a perspective view of a surgical instrument with anarticulable, interchangeable shaft;

FIG. 77 is a side view of the tip of the surgical instrument shown inFIG. 76;

FIGS. 78A-78E are graphs plotting gap size over time (FIG. 78A), firingcurrent over time (FIG. 78B), tissue compression over time (FIG. 78C),anvil strain over time (FIG. 78D), and trigger force over time (FIG.78E);

FIG. 79 is a graph plotting tissue displacement as a function of tissuecompression for normal tissues;

FIG. 80 is a graph plotting tissue displacement as a function of tissuecompression to distinguish normal and diseased tissues;

FIG. 81 illustrates a perspective view of a surgical instrument inaccordance with one aspect;

FIG. 82 illustrates an exploded view of the end effector of the surgicalinstrument of FIG. 81 in accordance with one aspect;

FIG. 83 illustrates a partial side view of a handle of the surgicalinstrument of FIG. 81 in accordance with one aspect;

FIG. 84 illustrates a cross-sectional view of an end effector of thesurgical instrument of FIG. 81 in accordance with one aspect;

FIG. 85 illustrates a logic diagram of a process in accordance with oneaspect;

FIG. 86 illustrates a logic diagram of a feedback system in accordancewith one aspect;

FIG. 87 illustrates a logic diagram of a feedback system in accordancewith one aspect;

FIG. 88 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 89 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 90 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 91 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 92 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 93 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 94 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 95 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 96 illustrates a feedback indicator of a feedback system inaccordance with one aspect;

FIG. 97 is a schematic depicting control systems of the modular surgicalinstrument system of FIG. 1, according to various aspects of the presentdisclosure;

FIG. 98 is a logic diagram of a method for implementing a surgicalfunction with the modular surgical instrument system of FIG. 1,according to various aspects of the present disclosure;

FIG. 99 depicts an example medical device that can include one or moreaspects of the present disclosure;

FIG. 100 depicts an example end-effector of a medical device that caninclude one or more aspects of the present disclosure;

FIG. 101 also depicts an example end-effector of a medical device thatcan include one or more aspects of the present disclosure;

FIG. 102 is a diagram of a smart sensor component in accordance with anaspect the present disclosure;

FIG. 103 is a logic diagram illustrating one aspect of a process forcalibrating a first sensor in response to an input from a second sensor;

FIG. 104 is a logic diagram illustrating one aspect of a process foradjusting a measurement of a first sensor in response to a plurality ofsecondary sensors;

FIG. 105 illustrates one aspect of a circuit configured to convertsignals from a first sensor and a plurality of secondary sensors intodigital signals receivable by a processor;

FIG. 106 is a logic diagram illustrating one aspect of a process forselecting the most reliable output from a plurality of redundantsensors;

FIG. 107 illustrates a sideways cross-sectional view of one aspect of anend effector comprising a magnet and a magnetic field sensor incommunication with processor;

FIGS. 108-110 illustrate one aspect of an end effector that comprises amagnet where FIG. 108 illustrates a perspective cutaway view of theanvil and the magnet, FIG. 109 illustrates a side cutaway view of theanvil and the magnet, and FIG. 110 illustrates a top cutaway view of theanvil and the magnet;

FIG. 111 illustrates one aspect of an end effector that is operable touse conductive surfaces at the distal contact point to create anelectrical connection;

FIG. 112 illustrates one aspect of an exploded view of a staplecartridge that comprises a flex cable connected to a magnetic fieldsensor and processor;

FIG. 113 illustrates the end effector shown in FIG. 112 with a flexcable and without the shaft assembly;

FIGS. 114 and 115 illustrate an elongated channel portion of an endeffector without the anvil or the staple cartridge, to illustrate howthe flex cable shown in FIG. 113 can be seated within the elongatedchannel;

FIG. 116 illustrates a flex cable, shown in FIGS. 113-115, alone;

FIG. 117 illustrates a close up view of the elongated channel shown inFIGS. 114 and 115 with a staple cartridge coupled thereto;

FIGS. 118 and 119 illustrate one aspect of a distal sensor plug whereFIG. 118 illustrates a cutaway view of the distal sensor plug and FIG.119 further illustrates the magnetic field sensor and the processoroperatively coupled to the flex board such that they are capable ofcommunicating;

FIG. 120 illustrates an aspect of an end effector with a flex cableoperable to provide power to sensors and electronics in the distal tipof the anvil portion;

FIGS. 121-123 illustrate the operation of the articulation joint andflex cable of the end effector where FIG. 121 illustrates a top view ofthe end effector with the end effector pivoted −45 degrees with respectto the shaft assembly, FIG. 122 illustrates a top view of the endeffector, and FIG. 123 illustrates a top view of the end effector withthe end effector pivoted +45 degrees with respect to the shaft assembly;

FIG. 124 illustrates cross-sectional view of the distal tip of an aspectof an anvil with sensors and electronics; and

FIG. 125 illustrates a cutaway view of the distal tip of the anvil.

FIG. 126 is a partial cross-sectional view of a handle of a surgicalinstrument comprising a battery and a battery lock in accordance with atleast one embodiment;

FIG. 127 is partial cross-sectional view of the handle of FIG. 126illustrating the battery lock in an unlocked configuration;

FIG. 128 is a partial cross-sectional view of the handle of FIG. 126illustrating the battery lock in a locked configuration;

FIG. 129 is a partial cross-sectional view of a handle of a surgicalinstrument comprising a battery lockout in accordance with at least oneembodiment illustrated in an unlocked configuration;

FIG. 130 is a partial cross-sectional view of the handle of FIG. 129illustrating the battery lockout in a locked-out configuration;

FIG. 131 is a partial cross-sectional view of a battery lockout inaccordance with an alternative embodiment illustrated in a locked-outconfiguration;

FIG. 132 depicts a surgical instrument system comprising a motorincluding a shaft, a gear train, an output shaft operably coupled to themotor shaft, and power generation means mounted to the motor shaft inaccordance with at least one embodiment;

FIG. 133 depicts the motor shaft of FIG. 132 which includes a straingauge and means for transmitting information from the motor shaft, i.e.,a rotating plane, to a stationary plane mounted to the motor shaft and,in addition, means for interpreting the information being transmittedfrom the motor shaft;

FIG. 134 is a perspective view of an end effector of a surgical staplinginstrument including a cartridge channel, a staple cartridge positionedin the cartridge channel, and an anvil;

FIG. 135 is a cross-sectional elevational view of the surgical staplinginstrument of FIG. 134 illustrating a sled and a firing member in anunfired position;

FIG. 136 is a detail view depicting the sled of FIG. 135 in a partiallyadvanced position and the firing member in its unfired position;

FIG. 137 is a perspective view of the staple cartridge of FIG. 134 priorto being inserted into the cartridge channel of FIG. 134;

FIG. 138 is a perspective view of the staple cartridge of FIG. 134 fullyseated in the cartridge channel of FIG. 134;

FIG. 139 is a schematic of the staple cartridge and cartridge channel ofFIG. 134 and the sled and the firing member of FIG. 135 depicting amis-insertion of the staple cartridge into the cartridge channel and theeffect on the sled that such a mis-insertion can cause;

FIG. 140 is a partial perspective view of an end effector of a surgicalstapling instrument in accordance with at least one embodiment includinga sensor configured to sense whether a staple cartridge has beenmis-inserted in the manner depicted in FIG. 139;

FIG. 141 is a partial perspective view of an end effector of a surgicalstapling instrument in accordance with at least one embodiment includinga sensor configured to detect whether the sled has been unintentionallyadvanced;

FIG. 142 is a partial perspective view of the end effector of FIG. 141illustrating the sled in an unintentionally advanced position;

FIG. 143 is a cross-sectional view of the sensor of FIG. 141 inaccordance with at least one embodiment; and

FIG. 144 is a cross-sectional view of the sensor of FIG. 141 inaccordance with at least one alternative embodiment.

DESCRIPTION

Applicant of the present application owns the following patentapplications that were filed on Mar. 6, 2015 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/640,795, entitled MULTIPLE LEVELTHRESHOLDS TO MODIFY OPERATION OF POWERED SURGICAL INSTRUMENTS; now U.S.Patent Application Publication No. 2016/0256185;

U.S. patent application Ser. No. 14/640,832, entitled ADAPTIVE TISSUECOMPRESSION TECHNIQUES TO ADJUST CLOSURE RATES FOR MULTIPLE TISSUETYPES; now U.S. Patent Application Publication No. 2016/0256154;

U.S. patent application Ser. No. 14/640,935, entitled OVERLAID MULTISENSOR RADIO FREQUENCY (RF) ELECTRODE SYSTEM TO MEASURE TISSUECOMPRESSION; now U.S. Patent Application Publication No. 2016/0256071;

U.S. patent application Ser. No. 14/640,831, entitled MONITORING SPEEDCONTROL AND PRECISION INCREMENTING OF MOTOR FOR POWERED SURGICALINSTRUMENTS; now U.S. Patent Application Publication No. 2016/0256153;

U.S. patent application Ser. No. 14/640,859, entitled TIME DEPENDENTEVALUATION OF SENSOR DATA TO DETERMINE STABILITY, CREEP, ANDVISCOELASTIC ELEMENTS OF MEASURES; now U.S. Patent ApplicationPublication No. 2016/0256187;

U.S. patent application Ser. No. 14/640,817, entitled INTERACTIVEFEEDBACK SYSTEM FOR POWERED SURGICAL INSTRUMENTS; now U.S. PatentApplication Publication No. 2016/0256186;

U.S. patent application Ser. No. 14/640,844, entitled CONTROL TECHNIQUESAND SUB-PROCESSOR CONTAINED WITHIN MODULAR SHAFT WITH SELECT CONTROLPROCESSING FROM HANDLE; now U.S. Patent Application Publication No.2016/0256155;

U.S. patent application Ser. No. 14/640,837, entitled SMART SENSORS WITHLOCAL SIGNAL PROCESSING; now U.S. Patent Application Publication No.2016/0256163;

U.S. patent application Ser. No. 14/640,780, entitled SURGICALINSTRUMENT COMPRISING A LOCKABLE BATTERY HOUSING; now U.S. PatentApplication Publication No. 2016/0256161;

U.S. patent application Ser. No. 14/640,765, entitled SYSTEM FORDETECTING THE MIS-INSERTION OF A STAPLE CARTRIDGE INTO A SURGICALSTAPLER; now U.S. Patent Application Publication No. 2016/0256160; and

U.S. patent application Ser. No. 14/640,799, entitled SIGNAL AND POWERCOMMUNICATION SYSTEM POSITIONED ON A ROTATABLE SHAFT; now U.S. PatentApplication Publication No. 2016/0256162.

Applicant of the present application owns the following patentapplications that were filed on Feb. 27, 2015, and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/633,576, entitled SURGICALINSTRUMENT SYSTEM COMPRISING AN INSPECTION STATION; now U.S. PatentApplication Publication No. 2016/0249919;

U.S. patent application Ser. No. 14/633,546, entitled SURGICAL APPARATUSCONFIGURED TO ASSESS WHETHER A PERFORMANCE PARAMETER OF THE SURGICALAPPARATUS IS WITHIN AN ACCEPTABLE PERFORMANCE BAND; now U.S. PatentApplication Publication No. 2016/0249915;

U.S. patent application Ser. No. 14/633,576, entitled SURGICAL CHARGINGSYSTEM THAT CHARGES AND/OR CONDITIONS ONE OR MORE BATTERIES; now U.S.Patent Application Publication No. 2016/0249919;

U.S. patent application Ser. No. 14/633,566, entitled CHARGING SYSTEMTHAT ENABLES EMERGENCY RESOLUTIONS FOR CHARGING A BATTERY; now U.S.Patent Application Publication No. 2016/0249918;

U.S. patent application Ser. No. 14/633,555, entitled SYSTEM FORMONITORING WHETHER A SURGICAL INSTRUMENT NEEDS TO BE SERVICED; now U.S.Patent Application Publication No. 2016/0249916;

U.S. patent application Ser. No. 14/633,542, entitled REINFORCED BATTERYFOR A SURGICAL INSTRUMENT; now U.S. Patent Application Publication No.2016/0249908;

U.S. patent application Ser. No. 14/633,548, entitled POWER ADAPTER FORA SURGICAL INSTRUMENT; now U.S. Patent Application Publication No.2016/0249909;

U.S. patent application Ser. No. 14/633,526, entitled ADAPTABLE SURGICALINSTRUMENT HANDLE; now U.S. Patent Application Publication No.2016/0249945;

U.S. patent application Ser. No. 14/633,541, entitled MODULAR STAPLINGASSEMBLY; now U.S. Patent Application Publication No. 2016/0249927; and

U.S. patent application Ser. No. 14/633,562, entitled SURGICAL APPARATUSCONFIGURED TO TRACK AN END-OF-LIFE PARAMETER; now U.S. PatentApplication Publication No. 2016/0249917.

Applicant of the present application owns the following patentapplications that were filed on Dec. 18, 2014 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/574,478, entitled SURGICALINSTRUMENT SYSTEMS COMPRISING AN ARTICULATABLE END EFFECTOR AND MEANSFOR ADJUSTING THE FIRING STROKE OF A FIRING MEMBER; now U.S. PatentApplication Publication No. 2016/0174977;

U.S. patent application Ser. No. 14/574,483, entitled SURGICALINSTRUMENT ASSEMBLY COMPRISING LOCKABLE SYSTEMS; now U.S. PatentApplication Publication No. 2016/0174969;

U.S. patent application Ser. No. 14/575,139, entitled DRIVE ARRANGEMENTSFOR ARTICULATABLE SURGICAL INSTRUMENTS; now U.S. Patent ApplicationPublication No. 2016/0174978;

U.S. patent application Ser. No. 14/575,148, entitled LOCKINGARRANGEMENTS FOR DETACHABLE SHAFT ASSEMBLIES WITH ARTICULATABLE SURGICALEND EFFECTORS; now U.S. Patent Application Publication No. 2016/0174976;

U.S. patent application Ser. No. 14/575,130, entitled SURGICALINSTRUMENT WITH AN ANVIL THAT IS SELECTIVELY MOVABLE ABOUT A DISCRETENON-MOVABLE AXIS RELATIVE TO A STAPLE CARTRIDGE; now U.S. PatentApplication Publication No. 2016/0174972;

U.S. patent application Ser. No. 14/575,143, entitled SURGICALINSTRUMENTS WITH IMPROVED CLOSURE ARRANGEMENTS; now U.S. PatentApplication Publication No. 2016/0174983;

U.S. patent application Ser. No. 14/575,117, entitled SURGICALINSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND MOVABLE FIRING BEAMSUPPORT ARRANGEMENTS; now U.S. Patent Application Publication No.2016/0174975;

U.S. patent application Ser. No. 14/575,154, entitled SURGICALINSTRUMENTS WITH ARTICULATABLE END EFFECTORS AND IMPROVED FIRING BEAMSUPPORT ARRANGEMENTS; now U.S. Patent Application Publication No.2016/0174973;

U.S. patent application Ser. No. 14/574,493, entitled SURGICALINSTRUMENT ASSEMBLY COMPRISING A FLEXIBLE ARTICULATION SYSTEM; now U.S.Patent Application Publication No. 2016/0174970; and

U.S. patent application Ser. No. 14/574,500, entitled SURGICALINSTRUMENT ASSEMBLY COMPRISING A LOCKABLE ARTICULATION SYSTEM; now U.S.Patent Application Publication No. 2016/0174971.

Applicant of the present application owns the following patentapplications that were filed on Mar. 1, 2013 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 13/782,295, entitled ARTICULATABLESURGICAL INSTRUMENTS WITH CONDUCTIVE PATHWAYS FOR SIGNAL COMMUNICATION,now U.S. Pat. No. 9,700,309;

U.S. patent application Ser. No. 13/782,323, entitled ROTARY POWEREDARTICULATION JOINTS FOR SURGICAL INSTRUMENTS, now U.S. Pat. No.9,782,169;

U.S. patent application Ser. No. 13/782,338, entitled THUMBWHEEL SWITCHARRANGEMENTS FOR SURGICAL INSTRUMENTS, now U.S. Patent ApplicationPublication No. 2014/0249557;

U.S. patent application Ser. No. 13/782,499, entitled ELECTROMECHANICALSURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT, now U.S. Pat. No.9,358,003;

U.S. patent application Ser. No. 13/782,460, entitled MULTIPLE PROCESSORMOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS, now U.S. Pat. No.9,554,794;

U.S. patent application Ser. No. 13/782,358, entitled JOYSTICK SWITCHASSEMBLIES FOR SURGICAL INSTRUMENTS, now U.S. Pat. No. 9,326,767;

U.S. patent application Ser. No. 13/782,481, entitled SENSORSTRAIGHTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR, now U.S. Pat.No. 9,468,438;

U.S. patent application Ser. No. 13/782,518, entitled CONTROL METHODSFOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT PORTIONS, now U.S.Patent Application Publication No. 2014/0246475;

U.S. patent application Ser. No. 13/782,375, entitled ROTARY POWEREDSURGICAL INSTRUMENTS WITH MULTIPLE DEGREES OF FREEDOM, now U.S. Pat. No.9,398,911; and

U.S. patent application Ser. No. 13/782,536, entitled SURGICALINSTRUMENT SOFT STOP, now U.S. Pat. No. 9,307,986.

Applicant of the present application also owns the following patentapplications that were filed on Mar. 14, 2013 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 13/803,097, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, now U.S. Pat. No.9,687,230;

U.S. patent application Ser. No. 13/803,193, entitled CONTROLARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT, now U.S. Pat.No. 9,332,987;

U.S. patent application Ser. No. 13/803,053, entitled INTERCHANGEABLESHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT, now U.S. PatentApplication Publication No. 2014/0263564;

U.S. patent application Ser. No. 13/803,086, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. PatentApplication Publication No. 2014/0263541;

U.S. patent application Ser. No. 13/803,210, entitled SENSORARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS,now U.S. Patent Application Publication No. 2014/0263538;

U.S. patent application Ser. No. 13/803,148, entitled MULTI-FUNCTIONMOTOR FOR A SURGICAL INSTRUMENT, now U.S. Patent Application PublicationNo. 2014/0263554;

U.S. patent application Ser. No. 13/803,066, entitled DRIVE SYSTEMLOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now U.S. Pat. No.9,629,623;

U.S. patent application Ser. No. 13/803,117, entitled ARTICULATIONCONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS, now U.S. Pat. No.9,351,726;

U.S. patent application Ser. No. 13/803,130, entitled DRIVE TRAINCONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS, now U.S. Pat. No.9,351,727; and

U.S. patent application Ser. No. 13/803,159, entitled METHOD AND SYSTEMFOR OPERATING A SURGICAL INSTRUMENT, now U.S. Patent ApplicationPublication No. 2014/0277017.

Applicant of the present application also owns the following patentapplication that was filed on Mar. 7, 2014 and is herein incorporated byreference in its entirety:

U.S. patent application Ser. No. 14/200,111, entitled CONTROL SYSTEMSFOR SURGICAL INSTRUMENTS, now U.S. Pat. No. 9,629,629.

Applicant of the present application also owns the following patentapplications that were filed on Mar. 26, 2014 and are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/226,106, entitled POWER MANAGEMENTCONTROL SYSTEMS FOR SURGICAL INSTRUMENTS; now U.S. Patent ApplicationPublication No. 2015/0272582;

U.S. patent application Ser. No. 14/226,099, entitled STERILIZATIONVERIFICATION CIRCUIT; now U.S. Patent Application Publication No.2015/0272581;

U.S. patent application Ser. No. 14/226,094, entitled VERIFICATION OFNUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT; now U.S. Patent ApplicationPublication No. 2015/0272580;

U.S. patent application Ser. No. 14/226,117, entitled POWER MANAGEMENTTHROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL; now U.S.Patent Application Publication No. 2015/0272574;

U.S. patent application Ser. No. 14/226,075, entitled MODULAR POWEREDSURGICAL INSTRUMENT WITH DETACHABLE SHAFT ASSEMBLIES; now U.S. Pat. No.9,743,929;

U.S. patent application Ser. No. 14/226,093, entitled FEEDBACKALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS; now U.S.Patent Application Publication No. 2015/0272569;

U.S. patent application Ser. No. 14/226,116, entitled SURGICALINSTRUMENT UTILIZING SENSOR ADAPTATION; now U.S. Patent ApplicationPublication No. 2015/0272571;

U.S. patent application Ser. No. 14/226,071, entitled SURGICALINSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR; now U.S. Pat. No.9,690,362;

U.S. patent application Ser. No. 14/226,097, entitled SURGICALINSTRUMENT COMPRISING INTERACTIVE SYSTEMS; now U.S. Patent ApplicationPublication No. 2015/0272570;

U.S. patent application Ser. No. 14/226,126, entitled INTERFACE SYSTEMSFOR USE WITH SURGICAL INSTRUMENTS; now U.S. Patent ApplicationPublication No. 2015/0272572;

U.S. patent application Ser. No. 14/226,133, entitled MODULAR SURGICALINSTRUMENT SYSTEM; now U.S. Patent Application Publication No.2015/0272557;

U.S. patent application Ser. No. 14/226,081, entitled SYSTEMS ANDMETHODS FOR CONTROLLING A SEGMENTED CIRCUIT; now U.S. Patent ApplicationPublication No. 2015/0277471;

U.S. patent application Ser. No. 14/226,076, entitled POWER MANAGEMENTTHROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION; now U.S. Pat.No. 9,733,663;

U.S. patent application Ser. No. 14/226,111, entitled SURGICAL STAPLINGINSTRUMENT SYSTEM; now U.S. Pat. No. 9,750,499; and

U.S. patent application Ser. No. 14/226,125, entitled SURGICALINSTRUMENT COMPRISING A ROTATABLE SHAFT; now U.S. Patent ApplicationPublication No. 2015/0280384.

Applicant of the present application also owns the following patentapplications that were filed on Sep. 5, 2014 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/479,103, entitled CIRCUITRY ANDSENSORS FOR POWERED MEDICAL DEVICE; now U.S. Patent ApplicationPublication No. 2016/0066912;

U.S. patent application Ser. No. 14/479,119, entitled ADJUNCT WITHINTEGRATED SENSORS TO QUANTIFY TISSUE COMPRESSION; now U.S. Pat. No.9,724,094;

U.S. patent application Ser. No. 14/478,908, entitled MONITORING DEVICEDEGRADATION BASED ON COMPONENT EVALUATION; now U.S. Pat. No. 9,737,301;

U.S. patent application Ser. No. 14/478,895, entitled MULTIPLE SENSORSWITH ONE SENSOR AFFECTING A SECOND SENSOR'S OUTPUT OR INTERPRETATION;now U.S. Pat. No. 9,757,128;

U.S. patent application Ser. No. 14/479,110, entitled USE OF POLARITY OFHALL MAGNET DETECTION TO DETECT MISLOADED CARTRIDGE; now U.S. PatentApplication Publication No. 2016/0066915;

U.S. patent application Ser. No. 14/479,098, entitled SMART CARTRIDGEWAKE UP OPERATION AND DATA RETENTION; now U.S. Patent ApplicationPublication No. 2016/0066911;

U.S. patent application Ser. No. 14/479,115, entitled MULTIPLE MOTORCONTROL FOR POWERED MEDICAL DEVICE; now U.S. Patent ApplicationPublication No. 2016/0066916; and

U.S. patent application Ser. No. 14/479,108, entitled LOCAL DISPLAY OFTISSUE PARAMETER STABILIZATION; now U.S. Patent Application PublicationNo. 2016/0066913.

Applicant of the present application also owns the following patentapplications that were filed on Apr. 9, 2014 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/248,590, entitled MOTOR DRIVENSURGICAL INSTRUMENTS WITH LOCKABLE DUAL DRIVE SHAFTS, now U.S. PatentApplication Publication No. 2014/0305987;

U.S. patent application Ser. No. 14/248,581, entitled SURGICALINSTRUMENT COMPRISING A CLOSING DRIVE AND A FIRING DRIVE OPERATED FROMTHE SAME ROTATABLE OUTPUT, now U.S. Pat. No. 9,649,110;

U.S. patent application Ser. No. 14/248,595, entitled SURGICALINSTRUMENT SHAFT INCLUDING SWITCHES FOR CONTROLLING THE OPERATION OF THESURGICAL INSTRUMENT, now U.S. Patent Application Publication No.2014/0305988;

U.S. patent application Ser. No. 14/248,588, entitled POWERED LINEARSURGICAL STAPLER, now U.S. Patent Application Publication No.2014/0309666;

U.S. patent application Ser. No. 14/248,591, entitled TRANSMISSIONARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S. Patent ApplicationPublication No. 2014/0305991;

U.S. patent application Ser. No. 14/248,584, entitled MODULAR MOTORDRIVEN SURGICAL INSTRUMENTS WITH ALIGNMENT FEATURES FOR ALIGNING ROTARYDRIVE SHAFTS WITH SURGICAL END EFFECTOR SHAFTS, now U.S. PatentApplication Publication No. 2014/0305994;

U.S. patent application Ser. No. 14/248,587, entitled POWERED SURGICALSTAPLER, now U.S. Patent Application Publication No. 2014/0309665;

U.S. patent application Ser. No. 14/248,586, entitled DRIVE SYSTEMDECOUPLING ARRANGEMENT FOR A SURGICAL INSTRUMENT, now U.S. PatentApplication Publication No. 2014/0305990; and

U.S. patent application Ser. No. 14/248,607, entitled MODULAR MOTORDRIVEN SURGICAL INSTRUMENTS WITH STATUS INDICATION ARRANGEMENTS, nowU.S. Patent Application Publication No. 2014/0305992.

Applicant of the present application also owns the following patentapplications that were filed on Apr. 16, 2013 and which are each hereinincorporated by reference in their respective entireties:

U.S. Provisional Patent Application Ser. No. 61/812,365, entitledSURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A SINGLE MOTOR;

U.S. Provisional Patent Application Ser. No. 61/812,376, entitled LINEARCUTTER WITH POWER;

U.S. Provisional Patent Application Ser. No. 61/812,382, entitled LINEARCUTTER WITH MOTOR AND PISTOL GRIP;

U.S. Provisional Patent Application Ser. No. 61/812,385, entitledSURGICAL INSTRUMENT HANDLE WITH MULTIPLE ACTUATION MOTORS AND MOTORCONTROL; and

U.S. Provisional Patent Application Ser. No. 61/812,372, entitledSURGICAL INSTRUMENT WITH MULTIPLE FUNCTIONS PERFORMED BY A SINGLE MOTOR.

The present disclosure provides an overall understanding of theprinciples of the structure, function, manufacture, and use of thedevices and methods disclosed herein. One or more examples of theseaspects are illustrated in the accompanying drawings. Those of ordinaryskill in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting examples. The features illustrated ordescribed in connection with one example may be combined with thefeatures of other examples. Such modifications and variations areintended to be included within the scope of the present disclosure.

Reference throughout the specification to “various aspects,” “someaspects,” “one aspect,” or “an aspect”, or the like, means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in various aspects,” “in some aspects,” “in one aspect”, or“in an aspect”, or the like, in places throughout the specification arenot necessarily all referring to the same aspect. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more aspects. Thus, the particularfeatures, structures, or characteristics illustrated or described inconnection with one aspect may be combined, in whole or in part, withthe features structures, or characteristics of one or more other aspectswithout limitation. Such modifications and variations are intended to beincluded within the scope of the present disclosure.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various example devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, theperson of ordinary skill in the art will readily appreciate that thevarious methods and devices disclosed herein can be used in numeroussurgical procedures and applications including, for example, inconnection with open surgical procedures. As the present DetailedDescription proceeds, those of ordinary skill in the art will furtherappreciate that the various instruments disclosed herein can be insertedinto a body in any way, such as through a natural orifice, through anincision or puncture hole formed in tissue, etc. The working portions orend effector portions of the instruments can be inserted directly into apatient's body or can be inserted through an access device that has aworking channel through which the end effector and elongated shaft of asurgical instrument can be advanced.

FIGS. 1-6 depict a motor-driven surgical cutting and fasteninginstrument 10 that may or may not be reused. In the illustratedexamples, the instrument 10 includes a housing 12 that comprises ahandle assembly 14 that is configured to be grasped, manipulated andactuated by the clinician. The housing 12 is configured for operableattachment to an interchangeable shaft assembly 200 that has a surgicalend effector 300 operably coupled thereto that is configured to performone or more surgical tasks or procedures. As the present DetailedDescription proceeds, it will be understood that the various unique andnovel arrangements of the various forms of interchangeable shaftassemblies disclosed herein also may be effectively employed inconnection with robotically-controlled surgical systems. Thus, the term“housing” also may encompass a housing or similar portion of a roboticsystem that houses or otherwise operably supports at least one drivesystem that is configured to generate and apply at least one controlmotion which could be used to actuate the interchangeable shaftassemblies disclosed herein and their respective equivalents. The term“frame” may refer to a portion of a handheld surgical instrument. Theterm “frame” also may represent a portion of a robotically controlledsurgical instrument and/or a portion of the robotic system that may beused to operably control a surgical instrument. For example, theinterchangeable shaft assemblies disclosed herein may be employed withvarious robotic systems, instruments, components and methods disclosedin U.S. patent application Ser. No. 13/118,241, entitled SURGICALSTAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, nowU.S. Pat. No. 9,072,535. U.S. patent application Ser. No. 13/118,241,entitled SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS, now U.S. Pat. No. 9,072,535, is incorporated by referenceherein in its entirety.

The housing 12 depicted in FIGS. 1-3 is shown in connection with aninterchangeable shaft assembly 200 that includes an end effector 300that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 304 therein.The housing 12 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing12 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

FIG. 1 illustrates the surgical instrument 10 with an interchangeableshaft assembly 200 operably coupled thereto. FIGS. 2 and 3 illustrateattachment of the interchangeable shaft assembly 200 to the housing 12or handle assembly 14. As shown in FIG. 4, the handle assembly 14 maycomprise a pair of interconnectable handle housing segments 16 and 18that may be interconnected by screws, snap features, adhesive, etc. Inthe illustrated arrangement, the handle housing segments 16, 18cooperate to form a pistol grip portion 19 that can be gripped andmanipulated by the clinician. As will be discussed in further detailbelow, the handle assembly 14 operably supports a plurality of drivesystems therein that are configured to generate and apply variouscontrol motions to corresponding portions of the interchangeable shaftassembly that is operably attached thereto.

Referring now to FIG. 4, the handle assembly 14 may further include aframe 20 that operably supports a plurality of drive systems. Forexample, the frame 20 can operably support a “first” or closure drivesystem, generally designated as 30, which may be employed to applyclosing and opening motions to the interchangeable shaft assembly 200that is operably attached or coupled thereto. In at least one form, theclosure drive system 30 may include an actuator in the form of a closuretrigger 32 that is pivotally supported by the frame 20. Morespecifically, as illustrated in FIG. 4, the closure trigger 32 ispivotally coupled to the housing 14 by a pin 33. Such arrangementenables the closure trigger 32 to be manipulated by a clinician suchthat when the clinician grips the pistol grip portion 19 of the handleassembly 14, the closure trigger 32 may be easily pivoted from astarting or “unactuated” position to an “actuated” position and moreparticularly to a fully compressed or fully actuated position. Theclosure trigger 32 may be biased into the unactuated position by springor other biasing arrangement (not shown). In various forms, the closuredrive system 30 further includes a closure linkage assembly 34 that ispivotally coupled to the closure trigger 32. As shown in FIG. 4, theclosure linkage assembly 34 may include a first closure link 36 and asecond closure link 38 that are pivotally coupled to the closure trigger32 by a pin 35. The second closure link 38 also may be referred toherein as an “attachment member” and include a transverse attachment pin37.

Still referring to FIG. 4, it can be observed that the first closurelink 36 may have a locking wall or end 39 thereon that is configured tocooperate with a closure release assembly 60 that is pivotally coupledto the frame 20. In at least one form, the closure release assembly 60may comprise a release button assembly 62 that has a distally protrudinglocking pawl 64 formed thereon. The release button assembly 62 may bepivoted in a counterclockwise direction by a release spring (not shown).As the clinician depresses the closure trigger 32 from its unactuatedposition towards the pistol grip portion 19 of the handle assembly 14,the first closure link 36 pivots upward to a point wherein the lockingpawl 64 drops into retaining engagement with the locking wall 39 on thefirst closure link 36 thereby preventing the closure trigger 32 fromreturning to the unactuated position. See FIG. 18. Thus, the closurerelease assembly 60 serves to lock the closure trigger 32 in the fullyactuated position. When the clinician desires to unlock the closuretrigger 32 to permit it to be biased to the unactuated position, theclinician simply pivots the closure release button assembly 62 such thatthe locking pawl 64 is moved out of engagement with the locking wall 39on the first closure link 36. When the locking pawl 64 has been movedout of engagement with the first closure link 36, the closure trigger 32may pivot back to the unactuated position. Other closure trigger lockingand release arrangements also may be employed.

Further to the above, FIGS. 13-15 illustrate the closure trigger 32 inits unactuated position which is associated with an open, or unclamped,configuration of the shaft assembly 200 in which tissue can bepositioned between the jaws of the shaft assembly 200. FIGS. 16-18illustrate the closure trigger 32 in its actuated position which isassociated with a closed, or clamped, configuration of the shaftassembly 200 in which tissue is clamped between the jaws of the shaftassembly 200. Upon comparing FIGS. 14 and 17, the reader will appreciatethat, when the closure trigger 32 is moved from its unactuated position(FIG. 14) to its actuated position (FIG. 17), the closure release button62 is pivoted between a first position (FIG. 14) and a second position(FIG. 17). The rotation of the closure release button 62 can be referredto as being an upward rotation; however, at least a portion of theclosure release button 62 is being rotated toward the circuit board 100.Referring to FIG. 4, the closure release button 62 can include an arm 61extending therefrom and a magnetic element 63, such as a permanentmagnet, for example, mounted to the arm 61. When the closure releasebutton 62 is rotated from its first position to its second position, themagnetic element 63 can move toward the circuit board 100. The circuitboard 100 can include at least one sensor configured to detect themovement of the magnetic element 63. In at least one aspect, a magneticfield sensor 65, for example, can be mounted to the bottom surface ofthe circuit board 100. The magnetic field sensor 65 can be configured todetect changes in a magnetic field surrounding the magnetic field sensor65 caused by the movement of the magnetic element 63. The magnetic fieldsensor 65 can be in signal communication with a microcontroller 1500(FIG. 19), for example, which can determine whether the closure releasebutton 62 is in its first position, which is associated with theunactuated position of the closure trigger 32 and the open configurationof the end effector, its second position, which is associated with theactuated position of the closure trigger 32 and the closed configurationof the end effector, and/or any position between the first position andthe second position.

As used throughout the present disclosure, a magnetic field sensor maybe a Hall effect sensor, search coil, fluxgate, optically pumped,nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance,giant magnetoresistance, magnetic tunnel junctions, giantmagnetoimpedance, magnetostrictive/piezoelectric composites,magnetodiode, magnetotransistor, fiber optic, magnetooptic, andmicroelectromechanical systems-based magnetic sensors, among others.

In at least one form, the handle assembly 14 and the frame 20 mayoperably support another drive system referred to herein as a firingdrive system 80 that is configured to apply firing motions tocorresponding portions of the interchangeable shaft assembly attachedthereto. The firing drive system may 80 also be referred to herein as a“second drive system”. The firing drive system 80 may employ an electricmotor 82, located in the pistol grip portion 19 of the handle assembly14. In various forms, the motor 82 may be a DC brushed driving motorhaving a maximum rotation of, approximately, 25,000 RPM, for example. Inother arrangements, the motor may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor 82 may be powered by a power source 90 that inone form may comprise a removable power pack 92. As shown in FIG. 4, forexample, the power pack 92 may comprise a proximal housing portion 94that is configured for attachment to a distal housing portion 96. Theproximal housing portion 94 and the distal housing portion 96 areconfigured to operably support a plurality of batteries 98 therein.Batteries 98 may each comprise, for example, a Lithium Ion (“LI”) orother suitable battery. The distal housing portion 96 is configured forremovable operable attachment to a control circuit board assembly 100which is also operably coupled to the motor 82. A number of batteries 98may be connected in series may be used as the power source for thesurgical instrument 10. In addition, the power source 90 may bereplaceable and/or rechargeable.

As outlined above with respect to other various forms, the electricmotor 82 can include a rotatable shaft (not shown) that operablyinterfaces with a gear reducer assembly 84 that is mounted in meshingengagement with a with a set, or rack, of drive teeth 122 on alongitudinally-movable drive member 120. In use, a voltage polarityprovided by the power source 90 can operate the electric motor 82 in aclockwise direction wherein the voltage polarity applied to the electricmotor by the battery can be reversed in order to operate the electricmotor 82 in a counter-clockwise direction. When the electric motor 82 isrotated in one direction, the drive member 120 will be axially driven inthe distal direction “DD”. When the motor 82 is driven in the oppositerotary direction, the drive member 120 will be axially driven in aproximal direction “PD”. The handle assembly 14 can include a switchwhich can be configured to reverse the polarity applied to the electricmotor 82 by the power source 90. As with the other forms describedherein, the handle assembly 14 can also include a sensor that isconfigured to detect the position of the drive member 120 and/or thedirection in which the drive member 120 is being moved.

Actuation of the motor 82 can be controlled by a firing trigger 130 thatis pivotally supported on the handle assembly 14. The firing trigger 130may be pivoted between an unactuated position and an actuated position.The firing trigger 130 may be biased into the unactuated position by aspring 132 or other biasing arrangement such that when the clinicianreleases the firing trigger 130, it may be pivoted or otherwise returnedto the unactuated position by the spring 132 or biasing arrangement. Inat least one form, the firing trigger 130 can be positioned “outboard”of the closure trigger 32 as was discussed above. In at least one form,a firing trigger safety button 134 may be pivotally mounted to theclosure trigger 32 by pin 35. The safety button 134 may be positionedbetween the firing trigger 130 and the closure trigger 32 and have apivot arm 136 protruding therefrom. See FIG. 4. When the closure trigger32 is in the unactuated position, the safety button 134 is contained inthe handle assembly 14 where the clinician cannot readily access it andmove it between a safety position preventing actuation of the firingtrigger 130 and a firing position wherein the firing trigger 130 may befired. As the clinician depresses the closure trigger 32, the safetybutton 134 and the firing trigger 130 pivot down wherein they can thenbe manipulated by the clinician.

As discussed above, the handle assembly 14 can include a closure trigger32 and a firing trigger 130. Referring to FIGS. 14-18A, the firingtrigger 130 can be pivotably mounted to the closure trigger 32. Theclosure trigger 32 can include an arm 31 extending therefrom and thefiring trigger 130 can be pivotably mounted to the arm 31 about a pivotpin 33. When the closure trigger 32 is moved from its unactuatedposition (FIG. 14) to its actuated position (FIG. 17), the firingtrigger 130 can descend downwardly, as outlined above. After the safetybutton 134 has been moved to its firing position, referring primarily toFIG. 18A, the firing trigger 130 can be depressed to operate the motorof the surgical instrument firing system. In various instances, thehandle assembly 14 can include a tracking system, such as system 800,for example, configured to determine the position of the closure trigger32 and/or the position of the firing trigger 130. With primary referenceto FIGS. 14, 17, and 18A, the tracking system 800 can include a magneticelement, such as permanent magnet 802, for example, which is mounted toan arm 801 extending from the firing trigger 130. The tracking system800 can comprise one or more sensors, such as a first magnetic fieldsensor 803 and a second magnetic field sensor 804, for example, whichcan be configured to track the position of the magnet 802.

Upon comparing FIGS. 14 and 17, the reader will appreciate that, whenthe closure trigger 32 is moved from its unactuated position to itsactuated position, the magnet 802 can move between a first positionadjacent the first magnetic field sensor 803 and a second positionadjacent the second magnetic field sensor 804.

Upon comparing FIGS. 17 and 18A, the reader will further appreciatethat, when the firing trigger 130 is moved from an unfired position(FIG. 17) to a fired position (FIG. 18A), the magnet 802 can moverelative to the second magnetic field sensor 804. The sensors 803 and804 can track the movement of the magnet 802 and can be in signalcommunication with a microcontroller on the circuit board 100. With datafrom the first sensor 803 and/or the second sensor 804, themicrocontroller can determine the position of the magnet 802 along apredefined path and, based on that position, the microcontroller candetermine whether the closure trigger 32 is in its unactuated position,its actuated position, or a position therebetween. Similarly, with datafrom the first sensor 803 and/or the second sensor 804, themicrocontroller can determine the position of the magnet 802 along apredefined path and, based on that position, the microcontroller candetermine whether the firing trigger 130 is in its unfired position, itsfully fired position, or a position therebetween.

As indicated above, in at least one form, the longitudinally movabledrive member 120 has a rack of teeth 122 formed thereon for meshingengagement with a corresponding drive gear 86 of the gear reducerassembly 84. At least one form also includes a manually-actuatable“bailout” assembly 140 that is configured to enable the clinician tomanually retract the longitudinally movable drive member 120 should themotor 82 become disabled. The bailout assembly 140 may include a leveror bailout handle assembly 14 that is configured to be manually pivotedinto ratcheting engagement with teeth 124 also provided in the drivemember 120. Thus, the clinician can manually retract the drive member120 by using the bailout handle assembly 14 to ratchet the drive member120 in the proximal direction “PD”. U.S. Patent Application PublicationNo. 2010/0089970, now U.S. Pat. No. 8,608,045 discloses bailoutarrangements and other components, arrangements and systems that alsomay be employed with the various instruments disclosed herein. U.S.patent application Ser. No. 12/249,117, entitled POWERED SURGICALCUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM,U.S. Patent Application Publication No. 2010/0089970, now U.S. Pat. No.8,608,045, is hereby incorporated by reference in its entirety.

Turning now to FIGS. 1 and 7, the interchangeable shaft assembly 200includes a surgical end effector 300 that comprises an elongated channel302 that is configured to operably support a staple cartridge 304therein. The end effector 300 may further include an anvil 306 that ispivotally supported relative to the elongated channel 302. Theinterchangeable shaft assembly 200 may further include an articulationjoint 270 and an articulation lock 350 (FIG. 8) which can be configuredto releasably hold the end effector 300 in a desired position relativeto a shaft axis SA-SA. Details regarding the construction and operationof the end effector 300, the articulation joint 270 and the articulationlock 350 are set forth in U.S. patent application Ser. No. 13/803,086,filed Mar. 14, 2013, entitled ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING AN ARTICULATION LOCK, now U.S. Patent Application PublicationNo. 2014/0263541. The entire disclosure of U.S. patent application Ser.No. 13/803,086, filed Mar. 14, 2013, entitled ARTICULATABLE SURGICALINSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. Patent ApplicationPublication No. 2014/0263541, is hereby incorporated by referenceherein. As shown in FIGS. 7 and 8, the interchangeable shaft assembly200 can further include a proximal housing or nozzle 201 comprised ofnozzle portions 202 and 203. The interchangeable shaft assembly 200 canfurther include a closure tube 260 which can be utilized to close and/oropen the anvil 306 of the end effector 300. Primarily referring now toFIGS. 8 and 9, the shaft assembly 200 can include a spine 210 which canbe configured to fixably support a shaft frame portion 212 of thearticulation lock 350. See FIG. 8. The spine 210 can be configured to,one, slidably support a firing member 220 therein and, two, slidablysupport the closure tube 260 which extends around the spine 210. Thespine 210 can also be configured to slidably support a proximalarticulation driver 230. The articulation driver 230 has a distal end231 that is configured to operably engage the articulation lock 350. Thearticulation lock 350 interfaces with an articulation frame 352 that isadapted to operably engage a drive pin (not shown) on the end effectorframe (not shown). As indicated above, further details regarding theoperation of the articulation lock 350 and the articulation frame may befound in U.S. patent application Ser. No. 13/803,086, now U.S. PatentApplication Publication No. 2014/0263541. In various circumstances, thespine 210 can comprise a proximal end 211 which is rotatably supportedin a chassis 240. In one arrangement, for example, the proximal end 211of the spine 210 has a thread 214 formed thereon for threaded attachmentto a spine bearing 216 configured to be supported within the chassis240. See FIG. 7. Such an arrangement facilitates rotatable attachment ofthe spine 210 to the chassis 240 such that the spine 210 may beselectively rotated about a shaft axis SA-SA relative to the chassis240.

Referring primarily to FIG. 7, the interchangeable shaft assembly 200includes a closure shuttle 250 that is slidably supported within thechassis 240 such that it may be axially moved relative thereto. As shownin FIGS. 3 and 7, the closure shuttle 250 includes a pair ofproximally-protruding hooks 252 that are configured for attachment tothe attachment pin 37 that is attached to the second closure link 38 aswill be discussed in further detail below. A proximal end 261 of theclosure tube 260 is coupled to the closure shuttle 250 for relativerotation thereto. For example, a U shaped connector 263 is inserted intoan annular slot 262 in the proximal end 261 of the closure tube 260 andis retained within vertical slots 253 in the closure shuttle 250. SeeFIG. 7. Such an arrangement serves to attach the closure tube 260 to theclosure shuttle 250 for axial travel therewith while enabling theclosure tube 260 to rotate relative to the closure shuttle 250 about theshaft axis SA-SA. A closure spring 268 is journaled on the closure tube260 and serves to bias the closure tube 260 in the proximal direction“PD” which can serve to pivot the closure trigger into the unactuatedposition when the shaft assembly is operably coupled to the handleassembly 14.

In at least one form, the interchangeable shaft assembly 200 may furtherinclude an articulation joint 270. Other interchangeable shaftassemblies, however, may not be capable of articulation. As shown inFIG. 7, for example, the articulation joint 270 includes a double pivotclosure sleeve assembly 271. According to various forms, the doublepivot closure sleeve assembly 271 includes an end effector closuresleeve assembly 272 having upper and lower distally projecting tangs273, 274. An end effector closure sleeve assembly 272 includes ahorseshoe aperture 275 and a tab 276 for engaging an opening tab on theanvil 306 in the various manners described in U.S. patent applicationSer. No. 13/803,086, filed Mar. 14, 2013, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK, now U.S. PatentApplication Publication No. 2014/0263541, which has been incorporated byreference herein. As described in further detail therein, the horseshoeaperture 275 and tab 276 engage a tab on the anvil when the anvil 306 isopened. An upper double pivot link 277 includes upwardly projectingdistal and proximal pivot pins that engage respectively an upper distalpin hole in the upper proximally projecting tang 273 and an upperproximal pinhole in an upper distally projecting tang 264 on the closuretube 260. A lower double pivot link 278 includes upwardly projectingdistal and proximal pivot pins that engage respectively a lower distalpin hole in the lower proximally projecting tang 274 and a lowerproximal pin hole in the lower distally projecting tang 265. See alsoFIG. 8.

In use, the closure tube 260 is translated distally (direction “DD”) toclose the anvil 306, for example, in response to the actuation of theclosure trigger 32. The anvil 306 is closed by distally translating theclosure tube 260 and thus the shaft closure sleeve assembly 272, causingit to strike a proximal surface on the anvil 360 in the manner describedin the aforementioned reference U.S. patent application Ser. No.13/803,086, now U.S. Patent Application Publication No. 2014/0263541. Aswas also described in detail in that reference, the anvil 306 is openedby proximally translating the closure tube 260 and the shaft closuresleeve assembly 272, causing tab 276 and the horseshoe aperture 275 tocontact and push against the anvil tab to lift the anvil 306. In theanvil-open position, the shaft closure tube 260 is moved to its proximalposition.

As indicated above, the surgical instrument 10 may further include anarticulation lock 350 of the types and construction described in furtherdetail in U.S. patent application Ser. No. 13/803,086, now U.S. PatentApplication Publication No. 2014/0263541, which can be configured andoperated to selectively lock the end effector 300 in position. Sucharrangement enables the end effector 300 to be rotated, or articulated,relative to the shaft closure tube 260 when the articulation lock 350 isin its unlocked state. In such an unlocked state, the end effector 300can be positioned and pushed against soft tissue and/or bone, forexample, surrounding the surgical site within the patient in order tocause the end effector 300 to articulate relative to the closure tube260. The end effector 300 also may be articulated relative to theclosure tube 260 by an articulation driver 230.

As was also indicated above, the interchangeable shaft assembly 200further includes a firing member 220 that is supported for axial travelwithin the shaft spine 210. The firing member 220 includes anintermediate firing shaft portion 222 that is configured for attachmentto a distal cutting portion or knife bar 280. The firing member 220 alsomay be referred to herein as a “second shaft” and/or a “second shaftassembly”. As shown in FIGS. 8 and 9, the intermediate firing shaftportion 222 may include a longitudinal slot 223 in the distal endthereof which can be configured to receive a tab 284 on the proximal end282 of the distal knife bar 280. The longitudinal slot 223 and theproximal end 282 can be sized and configured to permit relative movementtherebetween and can comprise a slip joint 286. The slip joint 286 canpermit the intermediate firing shaft portion 222 of the firing drive 220to be moved to articulate the end effector 300 without moving, or atleast substantially moving, the knife bar 280. Once the end effector 300has been suitably oriented, the intermediate firing shaft portion 222can be advanced distally until a proximal sidewall of the longitudinalslot 223 comes into contact with the tab 284 in order to advance theknife bar 280 and fire the staple cartridge positioned within thechannel 302 As can be further seen in FIGS. 8 and 9, the shaft spine 210has an elongate opening or window 213 therein to facilitate assembly andinsertion of the intermediate firing shaft portion 222 into the shaftframe 210. Once the intermediate firing shaft portion 222 has beeninserted therein, a top frame segment 215 may be engaged with the shaftframe 212 to enclose the intermediate firing shaft portion 222 and knifebar 280 therein. Further description of the operation of the firingmember 220 may be found in U.S. patent application Ser. No. 13/803,086,now U.S. Patent Application Publication No. 2014/0263541.

Further to the above, the shaft assembly 200 can include a clutchassembly 400 which can be configured to selectively and releasablycouple the articulation driver 230 to the firing member 220. In oneform, the clutch assembly 400 includes a lock collar, or sleeve 402,positioned around the firing member 220 wherein the lock sleeve 402 canbe rotated between an engaged position in which the lock sleeve 402couples the articulation driver 360 to the firing member 220 and adisengaged position in which the articulation driver 360 is not operablycoupled to the firing member 200. When lock sleeve 402 is in its engagedposition, distal movement of the firing member 220 can move thearticulation driver 360 distally and, correspondingly, proximal movementof the firing member 220 can move the articulation driver 230proximally. When lock sleeve 402 is in its disengaged position, movementof the firing member 220 is not transmitted to the articulation driver230 and, as a result, the firing member 220 can move independently ofthe articulation driver 230. In various circumstances, the articulationdriver 230 can be held in position by the articulation lock 350 when thearticulation driver 230 is not being moved in the proximal or distaldirections by the firing member 220.

Referring primarily to FIG. 9, the lock sleeve 402 can comprise acylindrical, or an at least substantially cylindrical, body including alongitudinal aperture 403 defined therein configured to receive thefiring member 220. The lock sleeve 402 can comprisediametrically-opposed, inwardly-facing lock protrusions 404 and anoutwardly-facing lock member 406. The lock protrusions 404 can beconfigured to be selectively engaged with the firing member 220. Moreparticularly, when the lock sleeve 402 is in its engaged position, thelock protrusions 404 are positioned within a drive notch 224 defined inthe firing member 220 such that a distal pushing force and/or a proximalpulling force can be transmitted from the firing member 220 to the locksleeve 402. When the lock sleeve 402 is in its engaged position, thesecond lock member 406 is received within a drive notch 232 defined inthe articulation driver 230 such that the distal pushing force and/orthe proximal pulling force applied to the lock sleeve 402 can betransmitted to the articulation driver 230. In effect, the firing member220, the lock sleeve 402, and the articulation driver 230 will movetogether when the lock sleeve 402 is in its engaged position. On theother hand, when the lock sleeve 402 is in its disengaged position, thelock protrusions 404 may not be positioned within the drive notch 224 ofthe firing member 220 and, as a result, a distal pushing force and/or aproximal pulling force may not be transmitted from the firing member 220to the lock sleeve 402. Correspondingly, the distal pushing force and/orthe proximal pulling force may not be transmitted to the articulationdriver 230. In such circumstances, the firing member 220 can be slidproximally and/or distally relative to the lock sleeve 402 and theproximal articulation driver 230.

As shown in FIGS. 8-12, the shaft assembly 200 further includes a switchdrum 500 that is rotatably received on the closure tube 260. The switchdrum 500 comprises a hollow shaft segment 502 that has a shaft boss 504formed thereon for receive an outwardly protruding actuation pin 410therein. In various circumstances, the actuation pin 410 extends througha slot 267 into a longitudinal slot 408 provided in the lock sleeve 402to facilitate axial movement of the lock sleeve 402 when it is engagedwith the articulation driver 230. A rotary torsion spring 420 isconfigured to engage the boss 504 on the switch drum 500 and a portionof the nozzle housing 203 as shown in FIG. 10 to apply a biasing forceto the switch drum 500. The switch drum 500 can further comprise atleast partially circumferential openings 506 defined therein which,referring to FIGS. 5 and 6, can be configured to receive circumferentialmounts 204, 205 extending from the nozzle halves 202, 203 and permitrelative rotation, but not translation, between the switch drum 500 andthe proximal nozzle 201. As shown in those Figures, the mounts 204 and205 also extend through openings 266 in the closure tube 260 to beseated in recesses 211 in the shaft spine 210. However, rotation of thenozzle 201 to a point where the mounts 204, 205 reach the end of theirrespective slots 506 in the switch drum 500 will result in rotation ofthe switch drum 500 about the shaft axis SA-SA. Rotation of the switchdrum 500 will ultimately result in the rotation of eth actuation pin 410and the lock sleeve 402 between its engaged and disengaged positions.Thus, in essence, the nozzle 201 may be employed to operably engage anddisengage the articulation drive system with the firing drive system inthe various manners described in further detail in U.S. patentapplication Ser. No. 13/803,086, now U.S. Patent Application PublicationNo. 2014/0263541.

As also illustrated in FIGS. 8-12, the shaft assembly 200 can comprise aslip ring assembly 600 which can be configured to conduct electricalpower to and/or from the end effector 300 and/or communicate signals toand/or from the end effector 300, for example. The slip ring assembly600 can comprise a proximal connector flange 604 mounted to a chassisflange 242 extending from the chassis 240 and a distal connector flange601 positioned within a slot defined in the shaft housings 202, 203. Theproximal connector flange 604 can comprise a first face and the distalconnector flange 601 can comprise a second face which is positionedadjacent to and movable relative to the first face. The distal connectorflange 601 can rotate relative to the proximal connector flange 604about the shaft axis SA-SA. The proximal connector flange 604 cancomprise a plurality of concentric, or at least substantiallyconcentric, conductors 602 defined in the first face thereof. Aconnector 607 can be mounted on the proximal side of the connectorflange 601 and may have a plurality of contacts (not shown) wherein eachcontact corresponds to and is in electrical contact with one of theconductors 602. Such an arrangement permits relative rotation betweenthe proximal connector flange 604 and the distal connector flange 601while maintaining electrical contact therebetween. The proximalconnector flange 604 can include an electrical connector 606 which canplace the conductors 602 in signal communication with a shaft circuitboard 610 mounted to the shaft chassis 240, for example. In at least oneinstance, a wiring harness comprising a plurality of conductors canextend between the electrical connector 606 and the shaft circuit board610. The electrical connector 606 may extend proximally through aconnector opening 243 defined in the chassis mounting flange 242. SeeFIG. 7. U.S. patent application Ser. No. 13/800,067, entitled STAPLECARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, nowU.S. Patent Application Publication No. 2014/0263552, is incorporated byreference in its entirety. U.S. patent application Ser. No. 13/800,025,entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, filed on Mar.13, 2013, now U.S. Patent Application Publication No. 2014/0263551, isincorporated by reference in its entirety. Further details regardingslip ring assembly 600 may be found in U.S. patent application Ser. No.13/803,086, now U.S. Patent Application Publication No. 2014/0263541.

As discussed above, the shaft assembly 200 can include a proximalportion which is fixably mounted to the handle assembly 14 and a distalportion which is rotatable about a longitudinal axis. The rotatabledistal shaft portion can be rotated relative to the proximal portionabout the slip ring assembly 600, as discussed above. The distalconnector flange 601 of the slip ring assembly 600 can be positionedwithin the rotatable distal shaft portion. Moreover, further to theabove, the switch drum 500 can also be positioned within the rotatabledistal shaft portion. When the rotatable distal shaft portion isrotated, the distal connector flange 601 and the switch drum 500 can berotated synchronously with one another. In addition, the switch drum 500can be rotated between a first position and a second position relativeto the distal connector flange 601. When the switch drum 500 is in itsfirst position, the articulation drive system may be operably disengagedfrom the firing drive system and, thus, the operation of the firingdrive system may not articulate the end effector 300 of the shaftassembly 200. When the switch drum 500 is in its second position, thearticulation drive system may be operably engaged with the firing drivesystem and, thus, the operation of the firing drive system mayarticulate the end effector 300 of the shaft assembly 200. When theswitch drum 500 is moved between its first position and its secondposition, the switch drum 500 is moved relative to distal connectorflange 601. In various instances, the shaft assembly 200 can comprise atleast one sensor configured to detect the position of the switch drum500. Turning now to FIGS. 11 and 12, the distal connector flange 601 cancomprise a magnetic field sensor 605, for example, and the switch drum500 can comprise a magnetic element, such as permanent magnet 505, forexample. The magnetic field sensor 605 can be configured to detect theposition of the permanent magnet 505. When the switch drum 500 isrotated between its first position and its second position, thepermanent magnet 505 can move relative to the magnetic field sensor 605.In various instances, magnetic field sensor 605 can detect changes in amagnetic field created when the permanent magnet 505 is moved. Themagnetic field sensor 605 can be in signal communication with the shaftcircuit board 610 and/or the handle circuit board 100, for example.Based on the signal from the magnetic field sensor 605, amicrocontroller on the shaft circuit board 610 and/or the handle circuitboard 100 can determine whether the articulation drive system is engagedwith or disengaged from the firing drive system.

Referring again to FIGS. 3 and 7, the chassis 240 includes at least one,and preferably two, tapered attachment portions 244 formed thereon thatare adapted to be received within corresponding dovetail slots 702formed within a distal attachment flange portion 700 of the frame 20.Each dovetail slot 702 may be tapered or, stated another way, besomewhat V-shaped to seatingly receive the attachment portions 244therein. As can be further seen in FIGS. 3 and 7, a shaft attachment lug226 is formed on the proximal end of the intermediate firing shaft 222.As will be discussed in further detail below, when the interchangeableshaft assembly 200 is coupled to the handle assembly 14, the shaftattachment lug 226 is received in a firing shaft attachment cradle 126formed in the distal end 125 of the longitudinal drive member 120 asshown in FIGS. 3 and 6, for example.

Various shaft assemblies employ a latch system 710 for removablycoupling the shaft assembly 200 to the housing 12 and more specificallyto the frame 20. As shown in FIG. 7, for example, in at least one form,the latch system 710 includes a lock member or lock yoke 712 that ismovably coupled to the chassis 240. In the illustrated example, forexample, the lock yoke 712 has a U-shape with two spaced downwardlyextending legs 714. The legs 714 each have a pivot lug 716 formedthereon that are adapted to be received in corresponding holes 245formed in the chassis 240. Such arrangement facilitates pivotalattachment of the lock yoke 712 to the chassis 240. The lock yoke 712may include two proximally protruding lock lugs 714 that are configuredfor releasable engagement with corresponding lock detents or grooves 704in the distal attachment flange 700 of the frame 20. See FIG. 3. Invarious forms, the lock yoke 712 is biased in the proximal direction byspring or biasing member (not shown). Actuation of the lock yoke 712 maybe accomplished by a latch button 722 that is slidably mounted on alatch actuator assembly 720 that is mounted to the chassis 240. Thelatch button 722 may be biased in a proximal direction relative to thelock yoke 712. As will be discussed in further detail below, the lockyoke 712 may be moved to an unlocked position by biasing the latchbutton the in distal direction which also causes the lock yoke 712 topivot out of retaining engagement with the distal attachment flange 700of the frame 20. When the lock yoke 712 is in “retaining engagement”with the distal attachment flange 700 of the frame 20, the lock lugs 716are retainingly seated within the corresponding lock detents or grooves704 in the distal attachment flange 700.

When employing an interchangeable shaft assembly that includes an endeffector of the type described herein that is adapted to cut and fastentissue, as well as other types of end effectors, it may be desirable toprevent inadvertent detachment of the interchangeable shaft assemblyfrom the housing during actuation of the end effector. For example, inuse the clinician may actuate the closure trigger 32 to grasp andmanipulate the target tissue into a desired position. Once the targettissue is positioned within the end effector 300 in a desiredorientation, the clinician may then fully actuate the closure trigger 32to close the anvil 306 and clamp the target tissue in position forcutting and stapling. In that instance, the first drive system 30 hasbeen fully actuated. After the target tissue has been clamped in the endeffector 300, it may be desirable to prevent the inadvertent detachmentof the shaft assembly 200 from the housing 12. One form of the latchsystem 710 is configured to prevent such inadvertent detachment.

As can be most particularly seen in FIG. 7, the lock yoke 712 includesat least one and preferably two lock hooks 718 that are adapted tocontact corresponding lock lug portions 256 that are formed on theclosure shuttle 250. Referring to FIGS. 13-15, when the closure shuttle250 is in an unactuated position (i.e., the first drive system 30 isunactuated and the anvil 306 is open), the lock yoke 712 may be pivotedin a distal direction to unlock the interchangeable shaft assembly 200from the housing 12. When in that position, the lock hooks 718 do notcontact the lock lug portions 256 on the closure shuttle 250. However,when the closure shuttle 250 is moved to an actuated position (i.e., thefirst drive system 30 is actuated and the anvil 306 is in the closedposition), the lock yoke 712 is prevented from being pivoted to anunlocked position. See FIGS. 16-18. Stated another way, if the clinicianwere to attempt to pivot the lock yoke 712 to an unlocked position or,for example, the lock yoke 712 was in advertently bumped or contacted ina manner that might otherwise cause it to pivot distally, the lock hooks718 on the lock yoke 712 will contact the lock lugs 256 on the closureshuttle 250 and prevent movement of the lock yoke 712 to an unlockedposition.

Attachment of the interchangeable shaft assembly 200 to the handleassembly 14 will now be described with reference to FIG. 3. To commencethe coupling process, the clinician may position the chassis 240 of theinterchangeable shaft assembly 200 above or adjacent to the distalattachment flange 700 of the frame 20 such that the tapered attachmentportions 244 formed on the chassis 240 are aligned with the dovetailslots 702 in the frame 20. The clinician may then move the shaftassembly 200 along an installation axis IA that is perpendicular to theshaft axis SA-SA to seat the attachment portions 244 in “operableengagement” with the corresponding dovetail receiving slots 702. Indoing so, the shaft attachment lug 226 on the intermediate firing shaft222 will also be seated in the cradle 126 in the longitudinally movabledrive member 120 and the portions of pin 37 on the second closure link38 will be seated in the corresponding hooks 252 in the closure yoke250. As used herein, the term “operable engagement” in the context oftwo components means that the two components are sufficiently engagedwith each other so that upon application of an actuation motion thereto,the components may carry out their intended action, function and/orprocedure.

As discussed above, at least five systems of the interchangeable shaftassembly 200 can be operably coupled with at least five correspondingsystems of the handle assembly 14. A first system can comprise a framesystem which couples and/or aligns the frame or spine of the shaftassembly 200 with the frame 20 of the handle assembly 14. Another systemcan comprise a closure drive system 30 which can operably connect theclosure trigger 32 of the handle assembly 14 and the closure tube 260and the anvil 306 of the shaft assembly 200. As outlined above, theclosure tube attachment yoke 250 of the shaft assembly 200 can beengaged with the pin 37 on the second closure link 38. Another systemcan comprise the firing drive system 80 which can operably connect thefiring trigger 130 of the handle assembly 14 with the intermediatefiring shaft 222 of the shaft assembly 200.

As outlined above, the shaft attachment lug 226 can be operablyconnected with the cradle 126 of the longitudinal drive member 120.Another system can comprise an electrical system which can signal to acontroller in the handle assembly 14, such as microcontroller, forexample, that a shaft assembly, such as shaft assembly 200, for example,has been operably engaged with the handle assembly 14 and/or, two,conduct power and/or communication signals between the shaft assembly200 and the handle assembly 14. For instance, the shaft assembly 200 caninclude an electrical connector 1410 that is operably mounted to theshaft circuit board 610. The electrical connector 1410 is configured formating engagement with a corresponding electrical connector 1400 on thehandle control board 100. Further details regaining the circuitry andcontrol systems may be found in U.S. patent application Ser. No.13/803,086, the entire disclosure of which was previously incorporatedby reference herein. The fifth system may consist of the latching systemfor releasably locking the shaft assembly 200 to the handle assembly 14.

Referring again to FIGS. 2 and 3, the handle assembly 14 can include anelectrical connector 1400 comprising a plurality of electrical contacts.Turning now to FIG. 19, the electrical connector 1400 can comprise afirst contact 1401 a, a second contact 1401 b, a third contact 1401 c, afourth contact 1401 d, a fifth contact 1401 e, and a sixth contact 1401f, for example. While the illustrated example utilizes six contacts,other examples are envisioned which may utilize more than six contactsor less than six contacts.

As illustrated in FIG. 19, the first contact 1401 a can be in electricalcommunication with a transistor 1408, contacts 1401 b-1401 e can be inelectrical communication with a microcontroller 1500, and the sixthcontact 1401 f can be in electrical communication with a ground. Incertain circumstances, one or more of the electrical contacts 1401b-1401 e may be in electrical communication with one or more outputchannels of the microcontroller 1500 and can be energized, or have avoltage potential applied thereto, when the handle 1042 is in a poweredstate. In some circumstances, one or more of the electrical contacts1401 b-1401 e may be in electrical communication with one or more inputchannels of the microcontroller 1500 and, when the handle assembly 14 isin a powered state, the microcontroller 1500 can be configured to detectwhen a voltage potential is applied to such electrical contacts. When ashaft assembly, such as shaft assembly 200, for example, is assembled tothe handle assembly 14, the electrical contacts 1401 a-1401 f may notcommunicate with each other. When a shaft assembly is not assembled tothe handle assembly 14, however, the electrical contacts 1401 a-1401 fof the electrical connector 1400 may be exposed and, in somecircumstances, one or more of the contacts 1401 a-1401 f may beaccidentally placed in electrical communication with each other. Suchcircumstances can arise when one or more of the contacts 1401 a-1401 fcome into contact with an electrically conductive material, for example.When this occurs, the microcontroller 1500 can receive an erroneousinput and/or the shaft assembly 200 can receive an erroneous output, forexample. To address this issue, in various circumstances, the handleassembly 14 may be unpowered when a shaft assembly, such as shaftassembly 200, for example, is not attached to the handle assembly 14.

In other circumstances, the handle 1042 can be powered when a shaftassembly, such as shaft assembly 200, for example, is not attachedthereto. In such circumstances, the microcontroller 1500 can beconfigured to ignore inputs, or voltage potentials, applied to thecontacts in electrical communication with the microcontroller 1500,i.e., contacts 1401 b-1401 e, for example, until a shaft assembly isattached to the handle assembly 14. Even though the microcontroller 1500may be supplied with power to operate other functionalities of thehandle assembly 14 in such circumstances, the handle assembly 14 may bein a powered-down state. In a way, the electrical connector 1400 may bein a powered-down state as voltage potentials applied to the electricalcontacts 1401 b-1401 e may not affect the operation of the handleassembly 14. The reader will appreciate that, even though contacts 1401b-1401 e may be in a powered-down state, the electrical contacts 1401 aand 1401 f, which are not in electrical communication with themicrocontroller 1500, may or may not be in a powered-down state. Forinstance, sixth contact 1401 f may remain in electrical communicationwith a ground regardless of whether the handle assembly 14 is in apowered-up or a powered-down state.

Furthermore, the transistor 1408, and/or any other suitable arrangementof transistors, such as transistor 1410, for example, and/or switchesmay be configured to control the supply of power from a power source1404, such as a battery 90 within the handle assembly 14, for example,to the first electrical contact 1401 a regardless of whether the handleassembly 14 is in a powered-up or a powered-down state. In variouscircumstances, the shaft assembly 200, for example, can be configured tochange the state of the transistor 1408 when the shaft assembly 200 isengaged with the handle assembly 14. In certain circumstances, furtherto the below, a magnetic field sensor 1402 can be configured to switchthe state of transistor 1410 which, as a result, can switch the state oftransistor 1408 and ultimately supply power from power source 1404 tofirst contact 1401 a. In this way, both the power circuits and thesignal circuits to the connector 1400 can be powered down when a shaftassembly is not installed to the handle assembly 14 and powered up whena shaft assembly is installed to the handle assembly 14.

In various circumstances, referring again to FIG. 19, the handleassembly 14 can include the magnetic field sensor 1402, for example,which can be configured to detect a detectable element, such as amagnetic element 1407 (FIG. 3), for example, on a shaft assembly, suchas shaft assembly 200, for example, when the shaft assembly is coupledto the handle assembly 14. The magnetic field sensor 1402 can be poweredby a power source 1406, such as a battery, for example, which can, ineffect, amplify the detection signal of the magnetic field sensor 1402and communicate with an input channel of the microcontroller 1500 viathe circuit illustrated in FIG. 19. Once the microcontroller 1500 has areceived an input indicating that a shaft assembly has been at leastpartially coupled to the handle assembly 14, and that, as a result, theelectrical contacts 1401 a-1401 f are no longer exposed, themicrocontroller 1500 can enter into its normal, or powered-up, operatingstate. In such an operating state, the microcontroller 1500 willevaluate the signals transmitted to one or more of the contacts 1401b-1401 e from the shaft assembly and/or transmit signals to the shaftassembly through one or more of the contacts 1401 b-1401 e in normal usethereof. In various circumstances, the shaft assembly 200 may have to befully seated before the magnetic field sensor 1402 can detect themagnetic element 1407. While a magnetic field sensor 1402 can beutilized to detect the presence of the shaft assembly 200, any suitablesystem of sensors and/or switches can be utilized to detect whether ashaft assembly has been assembled to the handle assembly 14, forexample. In this way, further to the above, both the power circuits andthe signal circuits to the connector 1400 can be powered down when ashaft assembly is not installed to the handle assembly 14 and powered upwhen a shaft assembly is installed to the handle assembly 14.

In various examples, as may be used throughout the present disclosure,any suitable magnetic field sensor may be employed to detect whether ashaft assembly has been assembled to the handle assembly 14, forexample. For example, the technologies used for magnetic field sensinginclude Hall effect sensor, search coil, fluxgate, optically pumped,nuclear precession, SQUID, Hall-effect, anisotropic magnetoresistance,giant magnetoresistance, magnetic tunnel junctions, giantmagnetoimpedance, magnetostrictive/piezoelectric composites,magnetodiode, magnetotransistor, fiber optic, magnetooptic, andmicroelectromechanical systems-based magnetic sensors, among others.

Referring to FIG. 19, the microcontroller 1500 may generally comprise amicroprocessor (“processor”) and one or more memory units operationallycoupled to the processor. By executing instruction code stored in thememory, the processor may control various components of the surgicalinstrument, such as the motor, various drive systems, and/or a userdisplay, for example. The microcontroller 1500 may be implemented usingintegrated and/or discrete hardware elements, software elements, and/ora combination of both. Examples of integrated hardware elements mayinclude processors, microprocessors, microcontrollers, integratedcircuits, application specific integrated circuits (ASIC), programmablelogic devices (PLD), digital signal processors (DSP), field programmablegate arrays (FPGA), logic gates, registers, semiconductor devices,chips, microchips, chip sets, microcontrollers, system-on-chip (SoC),and/or system-in-package (SIP). Examples of discrete hardware elementsmay include circuits and/or circuit elements such as logic gates, fieldeffect transistors, bipolar transistors, resistors, capacitors,inductors, and/or relays. In certain instances, the microcontroller 1500may include a hybrid circuit comprising discrete and integrated circuitelements or components on one or more substrates, for example.

Referring to FIG. 19, the microcontroller 1500 may be an LM 4F230H5QR,available from Texas Instruments, for example. In certain instances, theTexas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QEI) analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available. Other microcontrollersmay be readily substituted for use with the present disclosure.Accordingly, the present disclosure should not be limited in thiscontext.

As discussed above, the handle assembly 14 and/or the shaft assembly 200can include systems and configurations configured to prevent, or atleast reduce the possibility of, the contacts of the handle electricalconnector 1400 and/or the contacts of the shaft electrical connector1410 from becoming shorted out when the shaft assembly 200 is notassembled, or completely assembled, to the handle assembly 14. Referringto FIG. 3, the handle electrical connector 1400 can be at leastpartially recessed within a cavity 1409 defined in the handle frame 20.The six contacts 1401 a-1401 f of the electrical connector 1400 can becompletely recessed within the cavity 1409. Such arrangements can reducethe possibility of an object accidentally contacting one or more of thecontacts 1401 a-1401 f. Similarly, the shaft electrical connector 1410can be positioned within a recess defined in the shaft chassis 240 whichcan reduce the possibility of an object accidentally contacting one ormore of the contacts 1411 a-1411 f of the shaft electrical connector1410. With regard to the particular example depicted in FIG. 3, theshaft contacts 1411 a-1411 f can comprise male contacts. In at least oneexample, each shaft contact 1411 a-1411 f can comprise a flexibleprojection extending therefrom which can be configured to engage acorresponding handle contact 1401 a-1401 f, for example. The handlecontacts 1401 a-1401 f can comprise female contacts. In at least oneexample, each handle contact 1401 a-1401 f can comprise a flat surface,for example, against which the male shaft contacts 1401 a-1401 f canwipe, or slide, against and maintain an electrically conductiveinterface therebetween. In various instances, the direction in which theshaft assembly 200 is assembled to the handle assembly 14 can beparallel to, or at least substantially parallel to, the handle contacts1401 a-1401 f such that the shaft contacts 1411 a-1411 f slide againstthe handle contacts 1401 a-1401 f when the shaft assembly 200 isassembled to the handle assembly 14. In various alternative examples,the handle contacts 1401 a-1401 f can comprise male contacts and theshaft contacts 1411 a-1411 f can comprise female contacts. In certainalternative examples, the handle contacts 1401 a-1401 f and the shaftcontacts 1411 a-1411 f can comprise any suitable arrangement ofcontacts.

In various instances, the handle assembly 14 can comprise a connectorguard configured to at least partially cover the handle electricalconnector 1400 and/or a connector guard configured to at least partiallycover the shaft electrical connector 1410. A connector guard canprevent, or at least reduce the possibility of, an object accidentallytouching the contacts of an electrical connector when the shaft assemblyis not assembled to, or only partially assembled to, the handle. Aconnector guard can be movable. For instance, the connector guard can bemoved between a guarded position in which it at least partially guards aconnector and an unguarded position in which it does not guard, or atleast guards less of, the connector. In at least one example, aconnector guard can be displaced as the shaft assembly is beingassembled to the handle. For instance, if the handle comprises a handleconnector guard, the shaft assembly can contact and displace the handleconnector guard as the shaft assembly is being assembled to the handle.Similarly, if the shaft assembly comprises a shaft connector guard, thehandle can contact and displace the shaft connector guard as the shaftassembly is being assembled to the handle. In various instances, aconnector guard can comprise a door, for example. In at least oneinstance, the door can comprise a beveled surface which, when contactedby the handle or shaft, can facilitate the displacement of the door in acertain direction. In various instances, the connector guard can betranslated and/or rotated, for example. In certain instances, aconnector guard can comprise at least one film which covers the contactsof an electrical connector. When the shaft assembly is assembled to thehandle, the film can become ruptured. In at least one instance, the malecontacts of a connector can penetrate the film before engaging thecorresponding contacts positioned underneath the film.

As described above, the surgical instrument can include a system whichcan selectively power-up, or activate, the contacts of an electricalconnector, such as the electrical connector 1400, for example. Invarious instances, the contacts can be transitioned between anunactivated condition and an activated condition. In certain instances,the contacts can be transitioned between a monitored condition, adeactivated condition, and an activated condition. For instance, themicrocontroller 1500, for example, can monitor the contacts 1401 a-1401f when a shaft assembly has not been assembled to the handle assembly 14to determine whether one or more of the contacts 1401 a-1401 f may havebeen shorted. The microcontroller 1500 can be configured to apply a lowvoltage potential to each of the contacts 1401 a-1401 f and assesswhether only a minimal resistance is present at each of the contacts.Such an operating state can comprise the monitored condition. In theevent that the resistance detected at a contact is high, or above athreshold resistance, the microcontroller 1500 can deactivate thatcontact, more than one contact, or, alternatively, all of the contacts.Such an operating state can comprise the deactivated condition. If ashaft assembly is assembled to the handle assembly 14 and it is detectedby the microcontroller 1500, as discussed above, the microcontroller1500 can increase the voltage potential to the contacts 1401 a-1401 f.Such an operating state can comprise the activated condition.

The various shaft assemblies disclosed herein may employ sensors andvarious other components that require electrical communication with thecontroller in the housing. These shaft assemblies generally areconfigured to be able to rotate relative to the housing necessitating aconnection that facilitates such electrical communication between two ormore components that may rotate relative to each other. When employingend effectors of the types disclosed herein, the connector arrangementsmust be relatively robust in nature while also being somewhat compact tofit into the shaft assembly connector portion.

Referring to FIG. 20, a non-limiting form of the end effector 300 isillustrated. As described above, the end effector 300 may include theanvil 306 and the staple cartridge 304. In this non-limiting example,the anvil 306 is coupled to an elongate channel 198. For example,apertures 199 can be defined in the elongate channel 198 which canreceive pins 152 extending from the anvil 306 and allow the anvil 306 topivot from an open position to a closed position relative to theelongate channel 198 and staple cartridge 304. In addition, FIG. 20shows a firing bar 172, configured to longitudinally translate into theend effector 300. The firing bar 172 may be constructed from one solidsection, or in various examples, may include a laminate materialcomprising, for example, a stack of steel plates. A distally projectingend of the firing bar 172 can be attached to an E-beam 178 that can,among other things, assist in spacing the anvil 306 from a staplecartridge 304 positioned in the elongate channel 198 when the anvil 306is in a closed position. The E-beam 178 can also include a sharpenedcutting edge 182 which can be used to sever tissue as the E-beam 178 isadvanced distally by the firing bar 172. In operation, the E-beam 178can also actuate, or fire, the staple cartridge 304. The staplecartridge 304 can include a molded cartridge body 194 that holds aplurality of staples 191 resting upon staple drivers 192 withinrespective upwardly open staple cavities 195. A wedge sled 190 is drivendistally by the E-beam 178, sliding upon a cartridge tray 196 that holdstogether the various components of the replaceable staple cartridge 304.The wedge sled 190 upwardly cams the staple drivers 192 to force out thestaples 191 into deforming contact with the anvil 306 while a cuttingsurface 182 of the E-beam 178 severs clamped tissue.

Further to the above, the E-beam 178 can include upper pins 180 whichengage the anvil 306 during firing. The E-beam 178 can further includemiddle pins 184 and a bottom foot 186 which can engage various portionsof the cartridge body 194, cartridge tray 196 and elongate channel 198.When a staple cartridge 304 is positioned within the elongate channel198, a slot 193 defined in the cartridge body 194 can be aligned with aslot 197 defined in the cartridge tray 196 and a slot 189 defined in theelongate channel 198. In use, the E-beam 178 can slide through thealigned slots 193, 197, and 189 wherein, as indicated in FIG. 20, thebottom foot 186 of the E-beam 178 can engage a groove running along thebottom surface of channel 198 along the length of slot 189, the middlepins 184 can engage the top surfaces of cartridge tray 196 along thelength of longitudinal slot 197, and the upper pins 180 can engage theanvil 306. In such circumstances, the E-beam 178 can space, or limit therelative movement between, the anvil 306 and the staple cartridge 304 asthe firing bar 172 is moved distally to fire the staples from the staplecartridge 304 and/or incise the tissue captured between the anvil 306and the staple cartridge 304. Thereafter, the firing bar 172 and theE-beam 178 can be retracted proximally allowing the anvil 306 to beopened to release the two stapled and severed tissue portions (notshown).

Having described a surgical instrument 10 (FIGS. 1-4) in general terms,the description now turns to a detailed description of variouselectrical/electronic components of the surgical instrument 10. Turningnow to FIGS. 21A-21B, where one example of a segmented circuit 2000comprising a plurality of circuit segments 2002 a-2002 g is illustrated.The segmented circuit 2000 comprising the plurality of circuit segments2002 a-2002 g is configured to control a powered surgical instrument,such as, for example, the surgical instrument 10 illustrated in FIGS.1-18A, without limitation. The plurality of circuit segments 2002 a-2002g is configured to control one or more operations of the poweredsurgical instrument 10. A safety processor segment 2002 a (Segment 1)comprises a safety processor 2004. A primary processor segment 2002 b(Segment 2) comprises a primary processor 2006. The safety processor2004 and/or the primary processor 2006 are configured to interact withone or more additional circuit segments 2002 c-2002 g to controloperation of the powered surgical instrument 10. The primary processor2006 comprises a plurality of inputs coupled to, for example, one ormore circuit segments 2002 c-2002 g, a battery 2008, and/or a pluralityof switches 2058 a-2070. The segmented circuit 2000 may be implementedby any suitable circuit, such as, for example, a printed circuit boardassembly (PCBA) within the powered surgical instrument 10. It should beunderstood that the term processor as used herein includes anymicroprocessor, microcontroller, or other basic computing device thatincorporates the functions of a computer's central processing unit (CPU)on an integrated circuit or at most a few integrated circuits. Theprocessor is a multipurpose, programmable device that accepts digitaldata as input, processes it according to instructions stored in itsmemory, and provides results as output. It is an example of sequentialdigital logic, as it has internal memory. Processors operate on numbersand symbols represented in the binary numeral system.

In one aspect, the main processor 2006 may be any single core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one example, the safety processor 2004 may be asafety microcontroller platform comprising two microcontroller-basedfamilies such as TMS570 and RM4x known under the trade name Hercules ARMCortex R4, also by Texas Instruments. Nevertheless, other suitablesubstitutes for microcontrollers and safety processor may be employed,without limitation. In one example, the safety processor 2004 may beconfigured specifically for IEC 61508 and ISO 26262 safety criticalapplications, among others, to provide advanced integrated safetyfeatures while delivering scalable performance, connectivity, and memoryoptions.

In certain instances, the main processor 2006 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle SRAM, internal ROM loadedwith StellarisWare® software, 2 KB EEPROM, one or more PWM modules, oneor more QEI analog, one or more 12-bit ADC with 12 analog inputchannels, among other features that are readily available for theproduct datasheet. Other processors may be readily substituted and,accordingly, the present disclosure should not be limited in thiscontext.

In one aspect, the segmented circuit 2000 comprises an accelerationsegment 2002 c (Segment 3). The acceleration segment 2002 c comprises anacceleration sensor 2022. The acceleration sensor 2022 may comprise, forexample, an accelerometer. The acceleration sensor 2022 is configured todetect movement or acceleration of the powered surgical instrument 10.In some examples, input from the acceleration sensor 2022 is used, forexample, to transition to and from a sleep mode, identify an orientationof the powered surgical instrument, and/or identify when the surgicalinstrument has been dropped. In some examples, the acceleration segment2002 c is coupled to the safety processor 2004 and/or the primaryprocessor 2006.

In one aspect, the segmented circuit 2000 comprises a display segment2002 d (Segment 4). The display segment 2002 d comprises a displayconnector 2024 coupled to the primary processor 2006. The displayconnector 2024 couples the primary processor 2006 to a display 2028through one or more display driver integrated circuits 2026. The displaydriver integrated circuits 2026 may be integrated with the display 2028and/or may be located separately from the display 2028. The display 2028may comprise any suitable display, such as, for example, an organiclight-emitting diode (OLED) display, a liquid-crystal display (LCD),and/or any other suitable display. In some examples, the display segment2002 d is coupled to the safety processor 2004.

In some aspects, the segmented circuit 2000 comprises a shaft segment2002 e (Segment 5). The shaft segment 2002 e comprises one or morecontrols for a shaft 2004 coupled to the surgical instrument 10 and/orone or more controls for an end effector 2006 coupled to the shaft 2004.The shaft segment 2002 e comprises a shaft connector 2030 configured tocouple the primary processor 2006 to a shaft PCBA 2031. The shaft PCBA2031 comprises a first articulation switch 2036, a second articulationswitch 2032, and a shaft PCBA EEPROM 2034. In some examples, the shaftPCBA EEPROM 2034 comprises one or more parameters, routines, and/orprograms specific to the shaft 2004 and/or the shaft PCBA 2031. Theshaft PCBA 2031 may be coupled to the shaft 2004 and/or integral withthe surgical instrument 10. In some examples, the shaft segment 2002 ecomprises a second shaft EEPROM 2038. The second shaft EEPROM 2038comprises a plurality of algorithms, routines, parameters, and/or otherdata corresponding to one or more shafts 2004 and/or end effectors 2006which may be interfaced with the powered surgical instrument 10.

In some aspects, the segmented circuit 2000 comprises a position encodersegment 2002 f (Segment 6). The position encoder segment 2002 fcomprises one or more magnetic rotary position encoders 2040 a-2040 b.The one or more magnetic rotary position encoders 2040 a-2040 b areconfigured to identify the rotational position of a motor 2048, a shaft2004, and/or an end effector 2006 of the surgical instrument 10. In someexamples, the magnetic rotary position encoders 2040 a-2040 b may becoupled to the safety processor 2004 and/or the primary processor 2006.

In some aspects, the segmented circuit 2000 comprises a motor segment2002 g (Segment 7). The motor segment 2002 g comprises a motor 2048configured to control one or more movements of the powered surgicalinstrument 10. The motor 2048 is coupled to the primary processor 2006by an H-Bridge driver 2042 and one or more H-bridge field-effecttransistors (FETs) 2044. The H-bridge FETs 2044 are coupled to thesafety processor 2004. A motor current sensor 2046 is coupled in serieswith the motor 2048 to measure the current draw of the motor 2048. Themotor current sensor 2046 is in signal communication with the primaryprocessor 2006 and/or the safety processor 2004. In some examples, themotor 2048 is coupled to a motor electromagnetic interference (EMI)filter 2050.

In some aspects, the segmented circuit 2000 comprises a power segment2002 h (Segment 8). A battery 2008 is coupled to the safety processor2004, the primary processor 2006, and one or more of the additionalcircuit segments 2002 c-2002 g. The battery 2008 is coupled to thesegmented circuit 2000 by a battery connector 2010 and a current sensor2012. The current sensor 2012 is configured to measure the total currentdraw of the segmented circuit 2000. In some examples, one or morevoltage converters 2014 a, 2014 b, 2016 are configured to providepredetermined voltage values to one or more circuit segments 2002 a-2002g. For example, in some examples, the segmented circuit 2000 maycomprise 3.3V voltage converters 2014 a-2014 b and/or 5V voltageconverters 2016. A boost converter 2018 is configured to provide a boostvoltage up to a predetermined amount, such as, for example, up to 13V.The boost converter 2018 is configured to provide additional voltageand/or current during power intensive operations and prevent brownout orlow-power conditions.

In some aspects, the safety segment 2002 a comprises a motor powerinterrupt 2020. The motor power interrupt 2020 is coupled between thepower segment 2002 h and the motor segment 2002 g. The safety segment2002 a is configured to interrupt power to the motor segment 2002 g whenan error or fault condition is detected by the safety processor 2004and/or the primary processor 2006 as discussed in more detail herein.Although the circuit segments 2002 a-2002 g are illustrated with allcomponents of the circuit segments 2002 a-2002 h located in physicalproximity, one skilled in the art will recognize that a circuit segment2002 a-2002 h may comprise components physically and/or electricallyseparate from other components of the same circuit segment 2002 a-2002g. In some examples, one or more components may be shared between two ormore circuit segments 2002 a-2002 g.

In some aspects, a plurality of switches 2056-2070 are coupled to thesafety processor 2004 and/or the primary processor 2006. The pluralityof switches 2056-2070 may be configured to control one or moreoperations of the surgical instrument 10, control one or more operationsof the segmented circuit 2000, and/or indicate a status of the surgicalinstrument 10. For example, a bail-out door switch 2056 is configured toindicate the status of a bail-out door. A plurality of articulationswitches, such as, for example, a left side articulation left switch2058 a, a left side articulation right switch 2060 a, a left sidearticulation center switch 2062 a, a right side articulation left switch2058 b, a right side articulation right switch 2060 b, and a right sidearticulation center switch 2062 b are configured to control articulationof a shaft 2004 and/or an end effector 2006. A left side reverse switch2064 a and a right side reverse switch 2064 b are coupled to the primaryprocessor 2006. In some examples, the left side switches comprising theleft side articulation left switch 2058 a, the left side articulationright switch 2060 a, the left side articulation center switch 2062 a,and the left side reverse switch 2064 a are coupled to the primaryprocessor 2006 by a left flex connector 2072 a. The right side switchescomprising the right side articulation left switch 2058 b, the rightside articulation right switch 2060 b, the right side articulationcenter switch 2062 b, and the right side reverse switch 2064 b arecoupled to the primary processor 2006 by a right flex connector 2072 b.In some examples, a firing switch 2066, a clamp release switch 2068, anda shaft engaged switch 2070 are coupled to the primary processor 2006.

In some aspects, the plurality of switches 2056-2070 may comprise, forexample, a plurality of handle controls mounted to a handle of thesurgical instrument 10, a plurality of indicator switches, and/or anycombination thereof. In various examples, the plurality of switches2056-2070 allow a surgeon to manipulate the surgical instrument, providefeedback to the segmented circuit 2000 regarding the position and/oroperation of the surgical instrument, and/or indicate unsafe operationof the surgical instrument 10. In some examples, additional or fewerswitches may be coupled to the segmented circuit 2000, one or more ofthe switches 2056-2070 may be combined into a single switch, and/orexpanded to multiple switches. For example, in one example, one or moreof the left side and/or right side articulation switches 2058 a-2064 bmay be combined into a single multi-position switch.

In one aspect, the safety processor 2004 is configured to implement awatchdog function, among other safety operations. The safety processor2004 and the primary processor 2006 of the segmented circuit 2000 are insignal communication. A microprocessor alive heartbeat signal isprovided at output 2096. The acceleration segment 2002 c comprises anaccelerometer 2022 configured to monitor movement of the surgicalinstrument 10. In various examples, the accelerometer 2022 may be asingle, double, or triple axis accelerometer. The accelerometer 2022 maybe employed to measures proper acceleration that is not necessarily thecoordinate acceleration (rate of change of velocity). Instead, theaccelerometer sees the acceleration associated with the phenomenon ofweight experienced by a test mass at rest in the frame of reference ofthe accelerometer 2022. For example, the accelerometer 2022 at rest onthe surface of the earth will measure an acceleration g=9.8 m/s²(gravity) straight upwards, due to its weight. Another type ofacceleration that accelerometer 2022 can measure is g-forceacceleration. In various other examples, the accelerometer 2022 maycomprise a single, double, or triple axis accelerometer. Further, theacceleration segment 2002 c may comprise one or more inertial sensors todetect and measure acceleration, tilt, shock, vibration, rotation, andmultiple degrees-of-freedom (DoF). A suitable inertial sensor maycomprise an accelerometer (single, double, or triple axis), amagnetometer to measure a magnetic field in space such as the earth'smagnetic field, and/or a gyroscope to measure angular velocity.

In one aspect, the safety processor 2004 is configured to implement awatchdog function with respect to one or more circuit segments 2002c-2002 h, such as, for example, the motor segment 2002 g. In thisregards, the safety processor 2004 employs the watchdog function todetect and recover from malfunctions of the primary processor 2006.During normal operation, the safety processor 2004 monitors for hardwarefaults or program errors of the primary processor 2004 and to initiatecorrective action or actions. The corrective actions may include placingthe primary processor 2006 in a safe state and restoring normal systemoperation. In one example, the safety processor 2004 is coupled to atleast a first sensor. The first sensor measures a first property of thesurgical instrument 10 (FIGS. 1-4). In some examples, the safetyprocessor 2004 is configured to compare the measured property of thesurgical instrument 10 to a predetermined value. For example, in oneexample, a motor sensor 2040 a is coupled to the safety processor 2004.The motor sensor 2040 a provides motor speed and position information tothe safety processor 2004. The safety processor 2004 monitors the motorsensor 2040 a and compares the value to a maximum speed and/or positionvalue and prevents operation of the motor 2048 above the predeterminedvalues. In some examples, the predetermined values are calculated basedon real-time speed and/or position of the motor 2048, calculated fromvalues supplied by a second motor sensor 2040 b in communication withthe primary processor 2006, and/or provided to the safety processor 2004from, for example, a memory module coupled to the safety processor 2004.

In some aspects, a second sensor is coupled to the primary processor2006. The second sensor is configured to measure the first physicalproperty. The safety processor 2004 and the primary processor 2006 areconfigured to provide a signal indicative of the value of the firstsensor and the second sensor respectively. When either the safetyprocessor 2004 or the primary processor 2006 indicates a value outsideof an acceptable range, the segmented circuit 2000 prevents operation ofat least one of the circuit segments 2002 c-2002 h, such as, forexample, the motor segment 2002 g. For example, in the exampleillustrated in FIGS. 21A-21B, the safety processor 2004 is coupled to afirst motor position sensor 2040 a and the primary processor 2006 iscoupled to a second motor position sensor 2040 b. The motor positionsensors 2040 a, 2040 b may comprise any suitable motor position sensor,such as, for example, a magnetic angle rotary input comprising a sineand cosine output. The motor position sensors 2040 a, 2040 b providerespective signals to the safety processor 2004 and the primaryprocessor 2006 indicative of the position of the motor 2048.

The safety processor 2004 and the primary processor 2006 generate anactivation signal when the values of the first motor sensor 2040 a andthe second motor sensor 2040 b are within a predetermined range. Wheneither the primary processor 2006 or the safety processor 2004 to detecta value outside of the predetermined range, the activation signal isterminated and operation of at least one circuit segment 2002 c-2002 h,such as, for example, the motor segment 2002 g, is interrupted and/orprevented. For example, in some examples, the activation signal from theprimary processor 2006 and the activation signal from the safetyprocessor 2004 are coupled to an AND gate. The AND gate is coupled to amotor power switch 2020. The AND gate maintains the motor power switch2020 in a closed, or on, position when the activation signal from boththe safety processor 2004 and the primary processor 2006 are high,indicating a value of the motor sensors 2040 a, 2040 b within thepredetermined range. When either of the motor sensors 2040 a, 2040 bdetect a value outside of the predetermined range, the activation signalfrom that motor sensor 2040 a, 2040 b is set low, and the output of theAND gate is set low, opening the motor power switch 2020. In someexamples, the value of the first sensor 2040 a and the second sensor2040 b is compared, for example, by the safety processor 2004 and/or theprimary processor 2006. When the values of the first sensor and thesecond sensor are different, the safety processor 2004 and/or theprimary processor 2006 may prevent operation of the motor segment 2002g.

In some aspects, the safety processor 2004 receives a signal indicativeof the value of the second sensor 2040 b and compares the second sensorvalue to the first sensor value. For example, in one aspect, the safetyprocessor 2004 is coupled directly to a first motor sensor 2040 a. Asecond motor sensor 2040 b is coupled to a primary processor 2006, whichprovides the second motor sensor 2040 b value to the safety processor2004, and/or coupled directly to the safety processor 2004. The safetyprocessor 2004 compares the value of the first motor sensor 2040 to thevalue of the second motor sensor 2040 b. When the safety processor 2004detects a mismatch between the first motor sensor 2040 a and the secondmotor sensor 2040 b, the safety processor 2004 may interrupt operationof the motor segment 2002 g, for example, by cutting power to the motorsegment 2002 g.

In some aspects, the safety processor 2004 and/or the primary processor2006 is coupled to a first sensor 2040 a configured to measure a firstproperty of a surgical instrument and a second sensor 2040 b configuredto measure a second property of the surgical instrument. The firstproperty and the second property comprise a predetermined relationshipwhen the surgical instrument is operating normally. The safety processor2004 monitors the first property and the second property. When a valueof the first property and/or the second property inconsistent with thepredetermined relationship is detected, a fault occurs. When a faultoccurs, the safety processor 2004 takes at least one action, such as,for example, preventing operation of at least one of the circuitsegments, executing a predetermined operation, and/or resetting theprimary processor 2006. For example, the safety processor 2004 may openthe motor power switch 2020 to cut power to the motor circuit segment2002 g when a fault is detected.

In one aspect, the safety processor 2004 is configured to execute anindependent control algorithm. In operation, the safety processor 2004monitors the segmented circuit 2000 and is configured to control and/oroverride signals from other circuit components, such as, for example,the primary processor 2006, independently. The safety processor 2004 mayexecute a preprogrammed algorithm and/or may be updated or programmed onthe fly during operation based on one or more actions and/or positionsof the surgical instrument 10. For example, in one example, the safetyprocessor 2004 is reprogrammed with new parameters and/or safetyalgorithms each time a new shaft and/or end effector is coupled to thesurgical instrument 10. In some examples, one or more safety valuesstored by the safety processor 2004 are duplicated by the primaryprocessor 2006. Two-way error detection is performed to ensure valuesand/or parameters stored by either of the processors 2004, 2006 arecorrect.

In some aspects, the safety processor 2004 and the primary processor2006 implement a redundant safety check. The safety processor 2004 andthe primary processor 2006 provide periodic signals indicating normaloperation. For example, during operation, the safety processor 2004 mayindicate to the primary processor 2006 that the safety processor 2004 isexecuting code and operating normally. The primary processor 2006 may,likewise, indicate to the safety processor 2004 that the primaryprocessor 2006 is executing code and operating normally. In someexamples, communication between the safety processor 2004 and theprimary processor 2006 occurs at a predetermined interval. Thepredetermined interval may be constant or may be variable based on thecircuit state and/or operation of the surgical instrument 10.

FIG. 22 illustrates one example of a power assembly 2100 comprising ausage cycle circuit 2102 configured to monitor a usage cycle count ofthe power assembly 2100. The power assembly 2100 may be coupled to asurgical instrument 2110. The usage cycle circuit 2102 comprises aprocessor 2104 and a use indicator 2106. The use indicator 2106 isconfigured to provide a signal to the processor 2104 to indicate a useof the battery back 2100 and/or a surgical instrument 2110 coupled tothe power assembly 2100. A “use” may comprise any suitable action,condition, and/or parameter such as, for example, changing a modularcomponent of a surgical instrument 2110, deploying or firing adisposable component coupled to the surgical instrument 2110, deliveringelectrosurgical energy from the surgical instrument 2110, reconditioningthe surgical instrument 2110 and/or the power assembly 2100, exchangingthe power assembly 2100, recharging the power assembly 2100, and/orexceeding a safety limitation of the surgical instrument 2110 and/or thebattery back 2100.

In some instances, a usage cycle, or use, is defined by one or morepower assembly 2100 parameters. For example, in one instance, a usagecycle comprises using more than 5% of the total energy available fromthe power assembly 2100 when the power assembly 2100 is at a full chargelevel. In another instance, a usage cycle comprises a continuous energydrain from the power assembly 2100 exceeding a predetermined time limit.For example, a usage cycle may correspond to five minutes of continuousand/or total energy draw from the power assembly 2100. In someinstances, the power assembly 2100 comprises a usage cycle circuit 2102having a continuous power draw to maintain one or more components of theusage cycle circuit 2102, such as, for example, the use indicator 2106and/or a counter 2108, in an active state.

The processor 2104 maintains a usage cycle count. The usage cycle countindicates the number of uses detected by the use indicator 2106 for thepower assembly 2100 and/or the surgical instrument 2110. The processor2104 may increment and/or decrement the usage cycle count based on inputfrom the use indicator 2106. The usage cycle count is used to controlone or more operations of the power assembly 2100 and/or the surgicalinstrument 2110. For example, in some instances, a power assembly 2100is disabled when the usage cycle count exceeds a predetermined usagelimit. Although the instances discussed herein are discussed withrespect to incrementing the usage cycle count above a predeterminedusage limit, those skilled in the art will recognize that the usagecycle count may start at a predetermined amount and may be decrementedby the processor 2104. In this instance, the processor 2104 initiatesand/or prevents one or more operations of the power assembly 2100 whenthe usage cycle count falls below a predetermined usage limit.

The usage cycle count is maintained by a counter 2108. The counter 2108comprises any suitable circuit, such as, for example, a memory module,an analog counter, and/or any circuit configured to maintain a usagecycle count. In some instances, the counter 2108 is formed integrallywith the processor 2104. In other instances, the counter 2108 comprisesa separate component, such as, for example, a solid state memory module.In some instances, the usage cycle count is provided to a remote system,such as, for example, a central database. The usage cycle count istransmitted by a communications module 2112 to the remote system. Thecommunications module 2112 is configured to use any suitablecommunications medium, such as, for example, wired and/or wirelesscommunication. In some instances, the communications module 2112 isconfigured to receive one or more instructions from the remote system,such as, for example, a control signal when the usage cycle countexceeds the predetermined usage limit.

In some instances, the use indicator 2106 is configured to monitor thenumber of modular components used with a surgical instrument 2110coupled to the power assembly 2100. A modular component may comprise,for example, a modular shaft, a modular end effector, and/or any othermodular component. In some instances, the use indicator 2106 monitorsthe use of one or more disposable components, such as, for example,insertion and/or deployment of a staple cartridge within an end effectorcoupled to the surgical instrument 2110. The use indicator 2106comprises one or more sensors for detecting the exchange of one or moremodular and/or disposable components of the surgical instrument 2110.

In some instances, the use indicator 2106 is configured to monitorsingle patient surgical procedures performed while the power assembly2100 is installed. For example, the use indicator 2106 may be configuredto monitor firings of the surgical instrument 2110 while the powerassembly 2100 is coupled to the surgical instrument 2110. A firing maycorrespond to deployment of a staple cartridge, application ofelectrosurgical energy, and/or any other suitable surgical event. Theuse indicator 2106 may comprise one or more circuits for measuring thenumber of firings while the power assembly 2100 is installed. The useindicator 2106 provides a signal to the processor 2104 when a singlepatient procedure is performed and the processor 2104 increments theusage cycle count.

In some instances, the use indicator 2106 comprises a circuit configuredto monitor one or more parameters of the power source 2114, such as, forexample, a current draw from the power source 2114. The one or moreparameters of the power source 2114 correspond to one or more operationsperformable by the surgical instrument 2110, such as, for example, acutting and sealing operation. The use indicator 2106 provides the oneor more parameters to the processor 2104, which increments the usagecycle count when the one or more parameters indicate that a procedurehas been performed.

In some instances, the use indicator 2106 comprises a timing circuitconfigured to increment a usage cycle count after a predetermined timeperiod. The predetermined time period corresponds to a single patientprocedure time, which is the time required for an operator to perform aprocedure, such as, for example, a cutting and sealing procedure. Whenthe power assembly 2100 is coupled to the surgical instrument 2110, theprocessor 2104 polls the use indicator 2106 to determine when the singlepatient procedure time has expired. When the predetermined time periodhas elapsed, the processor 2104 increments the usage cycle count. Afterincrementing the usage cycle count, the processor 2104 resets the timingcircuit of the use indicator 2106.

In some instances, the use indicator 2106 comprises a time constant thatapproximates the single patient procedure time. In one example, theusage cycle circuit 2102 comprises a resistor-capacitor (RC) timingcircuit 2506. The RC timing circuit comprises a time constant defined bya resistor-capacitor pair. The time constant is defined by the values ofthe resistor and the capacitor. In one example, the usage cycle circuit2552 comprises a rechargeable battery and a clock. When the powerassembly 2100 is installed in a surgical instrument, the rechargeablebattery is charged by the power source. The rechargeable batterycomprises enough power to run the clock for at least the single patientprocedure time. The clock may comprise a real time clock, a processorconfigured to implement a time function, or any other suitable timingcircuit.

Referring still to FIG. 22, in some instances, the use indicator 2106comprises a sensor configured to monitor one or more environmentalconditions experienced by the power assembly 2100. For example, the useindicator 2106 may comprise an accelerometer. The accelerometer isconfigured to monitor acceleration of the power assembly 2100. The powerassembly 2100 comprises a maximum acceleration tolerance. Accelerationabove a predetermined threshold indicates, for example, that the powerassembly 2100 has been dropped. When the use indicator 2106 detectsacceleration above the maximum acceleration tolerance, the processor2104 increments a usage cycle count. In some instances, the useindicator 2106 comprises a moisture sensor. The moisture sensor isconfigured to indicate when the power assembly 2100 has been exposed tomoisture. The moisture sensor may comprise, for example, an immersionsensor configured to indicate when the power assembly 2100 has beenfully immersed in a cleaning fluid, a moisture sensor configured toindicate when moisture is in contact with the power assembly 2100 duringuse, and/or any other suitable moisture sensor.

In some instances, the use indicator 2106 comprises a chemical exposuresensor. The chemical exposure sensor is configured to indicate when thepower assembly 2100 has come into contact with harmful and/or dangerouschemicals. For example, during a sterilization procedure, aninappropriate chemical may be used that leads to degradation of thepower assembly 2100. The processor 2104 increments the usage cycle countwhen the use indicator 2106 detects an inappropriate chemical.

In some instances, the usage cycle circuit 2102 is configured to monitorthe number of reconditioning cycles experienced by the power assembly2100. A reconditioning cycle may comprise, for example, a cleaningcycle, a sterilization cycle, a charging cycle, routine and/orpreventative maintenance, and/or any other suitable reconditioningcycle. The use indicator 2106 is configured to detect a reconditioningcycle. For example, the use indicator 2106 may comprise a moisturesensor to detect a cleaning and/or sterilization cycle. In someinstances, the usage cycle circuit 2102 monitors the number ofreconditioning cycles experienced by the power assembly 2100 anddisables the power assembly 2100 after the number of reconditioningcycles exceeds a predetermined threshold.

The usage cycle circuit 2102 may be configured to monitor the number ofpower assembly 2100 exchanges. The usage cycle circuit 2102 incrementsthe usage cycle count each time the power assembly 2100 is exchanged.When the maximum number of exchanges is exceeded the usage cycle circuit2102 locks out the power assembly 2100 and/or the surgical instrument2110. In some instances, when the power assembly 2100 is coupled thesurgical instrument 2110, the usage cycle circuit 2102 identifies theserial number of the power assembly 2100 and locks the power assembly2100 such that the power assembly 2100 is usable only with the surgicalinstrument 2110. In some instances, the usage cycle circuit 2102increments the usage cycle each time the power assembly 2100 is removedfrom and/or coupled to the surgical instrument 2110.

In some instances, the usage cycle count corresponds to sterilization ofthe power assembly 2100. The use indicator 2106 comprises a sensorconfigured to detect one or more parameters of a sterilization cycle,such as, for example, a temperature parameter, a chemical parameter, amoisture parameter, and/or any other suitable parameter. The processor2104 increments the usage cycle count when a sterilization parameter isdetected. The usage cycle circuit 2102 disables the power assembly 2100after a predetermined number of sterilizations. In some instances, theusage cycle circuit 2102 is reset during a sterilization cycle, avoltage sensor to detect a recharge cycle, and/or any suitable sensor.The processor 2104 increments the usage cycle count when areconditioning cycle is detected. The usage cycle circuit 2102 isdisabled when a sterilization cycle is detected. The usage cycle circuit2102 is reactivated and/or reset when the power assembly 2100 is coupledto the surgical instrument 2110. In some instances, the use indicatorcomprises a zero power indicator. The zero power indicator changes stateduring a sterilization cycle and is checked by the processor 2104 whenthe power assembly 2100 is coupled to a surgical instrument 2110. Whenthe zero power indicator indicates that a sterilization cycle hasoccurred, the processor 2104 increments the usage cycle count.

A counter 2108 maintains the usage cycle count. In some instances, thecounter 2108 comprises a non-volatile memory module. The processor 2104increments the usage cycle count stored in the non-volatile memorymodule each time a usage cycle is detected. The memory module may beaccessed by the processor 2104 and/or a control circuit, such as, forexample, the control circuit 200. When the usage cycle count exceeds apredetermined threshold, the processor 2104 disables the power assembly2100. In some instances, the usage cycle count is maintained by aplurality of circuit components. For example, in one instance, thecounter 2108 comprises a resistor (or fuse) pack. After each use of thepower assembly 2100, a resistor (or fuse) is burned to an open position,changing the resistance of the resistor pack. The power assembly 2100and/or the surgical instrument 2110 reads the remaining resistance. Whenthe last resistor of the resistor pack is burned out, the resistor packhas a predetermined resistance, such as, for example, an infiniteresistance corresponding to an open circuit, which indicates that thepower assembly 2100 has reached its usage limit. In some instances, theresistance of the resistor pack is used to derive the number of usesremaining.

In some instances, the usage cycle circuit 2102 prevents further use ofthe power assembly 2100 and/or the surgical instrument 2110 when theusage cycle count exceeds a predetermined usage limit. In one instance,the usage cycle count associated with the power assembly 2100 isprovided to an operator, for example, utilizing a screen formedintegrally with the surgical instrument 2110. The surgical instrument2110 provides an indication to the operator that the usage cycle counthas exceeded a predetermined limit for the power assembly 2100, andprevents further operation of the surgical instrument 2110.

In some instances, the usage cycle circuit 2102 is configured tophysically prevent operation when the predetermined usage limit isreached. For example, the power assembly 2100 may comprise a shieldconfigured to deploy over contacts of the power assembly 2100 when theusage cycle count exceeds the predetermined usage limit. The shieldprevents recharge and use of the power assembly 2100 by covering theelectrical connections of the power assembly 2100.

In some instances, the usage cycle circuit 2102 is located at leastpartially within the surgical instrument 2110 and is configured tomaintain a usage cycle count for the surgical instrument 2110. FIG. 22illustrates one or more components of the usage cycle circuit 2102within the surgical instrument 2110 in phantom, illustrating thealternative positioning of the usage cycle circuit 2102. When apredetermined usage limit of the surgical instrument 2110 is exceeded,the usage cycle circuit 2102 disables and/or prevents operation of thesurgical instrument 2110. The usage cycle count is incremented by theusage cycle circuit 2102 when the use indicator 2106 detects a specificevent and/or requirement, such as, for example, firing of the surgicalinstrument 2110, a predetermined time period corresponding to a singlepatient procedure time, based on one or more motor parameters of thesurgical instrument 2110, in response to a system diagnostic indicatingthat one or more predetermined thresholds are met, and/or any othersuitable requirement. As discussed above, in some instances, the useindicator 2106 comprises a timing circuit corresponding to a singlepatient procedure time. In other instances, the use indicator 2106comprises one or more sensors configured to detect a specific eventand/or condition of the surgical instrument 2110.

In some instances, the usage cycle circuit 2102 is configured to preventoperation of the surgical instrument 2110 after the predetermined usagelimit is reached. In some instances, the surgical instrument 2110comprises a visible indicator to indicate when the predetermined usagelimit has been reached and/or exceeded. For example, a flag, such as ared flag, may pop-up from the surgical instrument 2110, such as from thehandle, to provide a visual indication to the operator that the surgicalinstrument 2110 has exceeded the predetermined usage limit. As anotherexample, the usage cycle circuit 2102 may be coupled to a display formedintegrally with the surgical instrument 2110. The usage cycle circuit2102 displays a message indicating that the predetermined usage limithas been exceeded. The surgical instrument 2110 may provide an audibleindication to the operator that the predetermined usage limit has beenexceeded. For example, in one instance, the surgical instrument 2110emits an audible tone when the predetermined usage limit is exceeded andthe power assembly 2100 is removed from the surgical instrument 2110.The audible tone indicates the last use of the surgical instrument 2110and indicates that the surgical instrument 2110 should be disposed orreconditioned.

In some instances, the usage cycle circuit 2102 is configured totransmit the usage cycle count of the surgical instrument 2110 to aremote location, such as, for example, a central database. The usagecycle circuit 2102 comprises a communications module 2112 configured totransmit the usage cycle count to the remote location. Thecommunications module 2112 may utilize any suitable communicationssystem, such as, for example, wired or wireless communications system.The remote location may comprise a central database configured tomaintain usage information. In some instances, when the power assembly2100 is coupled to the surgical instrument 2110, the power assembly 2100records a serial number of the surgical instrument 2110. The serialnumber is transmitted to the central database, for example, when thepower assembly 2100 is coupled to a charger. In some instances, thecentral database maintains a count corresponding to each use of thesurgical instrument 2110. For example, a bar code associated with thesurgical instrument 2110 may be scanned each time the surgicalinstrument 2110 is used. When the use count exceeds a predeterminedusage limit, the central database provides a signal to the surgicalinstrument 2110 indicating that the surgical instrument 2110 should bediscarded.

The surgical instrument 2110 may be configured to lock and/or preventoperation of the surgical instrument 2110 when the usage cycle countexceeds a predetermined usage limit. In some instances, the surgicalinstrument 2110 comprises a disposable instrument and is discarded afterthe usage cycle count exceeds the predetermined usage limit. In otherinstances, the surgical instrument 2110 comprises a reusable surgicalinstrument which may be reconditioned after the usage cycle countexceeds the predetermined usage limit. The surgical instrument 2110initiates a reversible lockout after the predetermined usage limit ismet. A technician reconditions the surgical instrument 2110 and releasesthe lockout, for example, utilizing a specialized technician keyconfigured to reset the usage cycle circuit 2102.

In some aspects, the segmented circuit 2000 is configured for sequentialstart-up. An error check is performed by each circuit segment 2002a-2002 g prior to energizing the next sequential circuit segment 2002a-2002 g. FIG. 23 illustrates one example of a process for sequentiallyenergizing a segmented circuit 2270, such as, for example, the segmentedcircuit 2000. When a battery 2008 is coupled to the segmented circuit2000, the safety processor 2004 is energized 2272. The safety processor2004 performs a self-error check 2274. When an error is detected 2276 a,the safety processor stops energizing the segmented circuit 2000 andgenerates an error code 2278 a. When no errors are detected 2276 b, thesafety processor 2004 initiates 2278 b power-up of the primary processor2006. The primary processor 2006 performs a self-error check. When noerrors are detected, the primary processor 2006 begins sequentialpower-up of each of the remaining circuit segments 2278 b. Each circuitsegment is energized and error checked by the primary processor 2006.When no errors are detected, the next circuit segment is energized 2278b. When an error is detected, the safety processor 2004 and/or theprimary process stops energizing the current segment and generates anerror 2278 a. The sequential start-up continues until all of the circuitsegments 2002 a-2002 g have been energized. In some examples, thesegmented circuit 2000 transitions from sleep mode following a similarsequential power-up process 11250.

FIG. 24 illustrates one aspect of a power segment 2302 comprising aplurality of daisy chained power converters 2314, 2316, 2318. The powersegment 2302 comprises a battery 2308. The battery 2308 is configured toprovide a source voltage, such as, for example, 12V. A current sensor2312 is coupled to the battery 2308 to monitor the current draw of asegmented circuit and/or one or more circuit segments. The currentsensor 2312 is coupled to an FET switch 2313. The battery 2308 iscoupled to one or more voltage converters 2309, 2314, 2316. An always onconverter 2309 provides a constant voltage to one or more circuitcomponents, such as, for example, a motion sensor 2322. The always onconverter 2309 comprises, for example, a 3.3V converter. The always onconverter 2309 may provide a constant voltage to additional circuitcomponents, such as, for example, a safety processor (not shown). Thebattery 2308 is coupled to a boost converter 2318. The boost converter2318 is configured to provide a boosted voltage above the voltageprovided by the battery 2308. For example, in the illustrated example,the battery 2308 provides a voltage of 12V. The boost converter 2318 isconfigured to boost the voltage to 13V. The boost converter 2318 isconfigured to maintain a minimum voltage during operation of a surgicalinstrument, for example, the surgical instrument 10 (FIGS. 1-4).Operation of a motor can result in the power provided to the primaryprocessor 2306 dropping below a minimum threshold and creating abrownout or reset condition in the primary processor 2306. The boostconverter 2318 ensures that sufficient power is available to the primaryprocessor 2306 and/or other circuit components, such as the motorcontroller 2343, during operation of the surgical instrument 10. In someexamples, the boost converter 2318 is coupled directly one or morecircuit components, such as, for example, an OLED display 2388.

The boost converter 2318 is coupled to one or more step-down convertersto provide voltages below the boosted voltage level. A first voltageconverter 2316 is coupled to the boost converter 2318 and provides afirst stepped-down voltage to one or more circuit components. In theillustrated example, the first voltage converter 2316 provides a voltageof 5V. The first voltage converter 2316 is coupled to a rotary positionencoder 2340. A FET switch 2317 is coupled between the first voltageconverter 2316 and the rotary position encoder 2340. The FET switch 2317is controlled by the processor 2306. The processor 2306 opens the FETswitch 2317 to deactivate the position encoder 2340, for example, duringpower intensive operations. The first voltage converter 2316 is coupledto a second voltage converter 2314 configured to provide a secondstepped-down voltage. The second stepped-down voltage comprises, forexample, 3.3V. The second voltage converter 2314 is coupled to aprocessor 2306. In some examples, the boost converter 2318, the firstvoltage converter 2316, and the second voltage converter 2314 arecoupled in a daisy chain configuration. The daisy chain configurationallows the use of smaller, more efficient converters for generatingvoltage levels below the boosted voltage level. The examples, however,are not limited to the particular voltage range(s) described in thecontext of this specification.

FIG. 25 illustrates one aspect of a segmented circuit 2400 configured tomaximize power available for critical and/or power intense functions.The segmented circuit 2400 comprises a battery 2408. The battery 2408 isconfigured to provide a source voltage such as, for example, 12V. Thesource voltage is provided to a plurality of voltage converters 2409,2418. An always-on voltage converter 2409 provides a constant voltage toone or more circuit components, for example, a motion sensor 2422 and asafety processor 2404. The always-on voltage converter 2409 is directlycoupled to the battery 2408. The always-on converter 2409 provides avoltage of 3.3V, for example. The examples, however, are not limited tothe particular voltage range(s) described in the context of thisspecification.

The segmented circuit 2400 comprises a boost converter 2418. The boostconverter 2418 provides a boosted voltage above the source voltageprovided by the battery 2408, such as, for example, 13V. The boostconverter 2418 provides a boosted voltage directly to one or morecircuit components, such as, for example, an OLED display 2488 and amotor controller 2443. By coupling the OLED display 2488 directly to theboost converter 2418, the segmented circuit 2400 eliminates the need fora power converter dedicated to the OLED display 2488. The boostconverter 2418 provides a boosted voltage to the motor controller 2443and the motor 2448 during one or more power intensive operations of themotor 2448, such as, for example, a cutting operation. The boostconverter 2418 is coupled to a step-down converter 2416. The step-downconverter 2416 is configured to provide a voltage below the boostedvoltage to one or more circuit components, such as, for example, 5V. Thestep-down converter 2416 is coupled to, for example, a FET switch 2451and a position encoder 2440. The FET switch 2451 is coupled to theprimary processor 2406. The primary processor 2406 opens the FET switch2451 when transitioning the segmented circuit 2400 to sleep mode and/orduring power intensive functions requiring additional voltage deliveredto the motor 2448. Opening the FET switch 2451 deactivates the positionencoder 2440 and eliminates the power draw of the position encoder 2440.The examples, however, are not limited to the particular voltagerange(s) described in the context of this specification.

The step-down converter 2416 is coupled to a linear converter 2414. Thelinear converter 2414 is configured to provide a voltage of, forexample, 3.3V. The linear converter 2414 is coupled to the primaryprocessor 2406. The linear converter 2414 provides an operating voltageto the primary processor 2406. The linear converter 2414 may be coupledto one or more additional circuit components. The examples, however, arenot limited to the particular voltage range(s) described in the contextof this specification.

The segmented circuit 2400 comprises a bailout switch 2456. The bailoutswitch 2456 is coupled to a bailout door on the surgical instrument 10.The bailout switch 2456 and the safety processor 2404 are coupled to anAND gate 2419. The AND gate 2419 provides an input to a FET switch 2413.When the bailout switch 2456 detects a bailout condition, the bailoutswitch 2456 provides a bailout shutdown signal to the AND gate 2419.When the safety processor 2404 detects an unsafe condition, such as, forexample, due to a sensor mismatch, the safety processor 2404 provides ashutdown signal to the AND gate 2419. In some examples, both the bailoutshutdown signal and the shutdown signal are high during normal operationand are low when a bailout condition or an unsafe condition is detected.When the output of the AND gate 2419 is low, the FET switch 2413 isopened and operation of the motor 2448 is prevented. In some examples,the safety processor 2404 utilizes the shutdown signal to transition themotor 2448 to an off state in sleep mode. A third input to the FETswitch 2413 is provided by a current sensor 2412 coupled to the battery2408. The current sensor 2412 monitors the current drawn by the circuit2400 and opens the FET switch 2413 to shut-off power to the motor 2448when an electrical current above a predetermined threshold is detected.The FET switch 2413 and the motor controller 2443 are coupled to a bankof FET switches 2445 configured to control operation of the motor 2448.

A motor current sensor 2446 is coupled in series with the motor 2448 toprovide a motor current sensor reading to a current monitor 2447. Thecurrent monitor 2447 is coupled to the primary processor 2406. Thecurrent monitor 2447 provides a signal indicative of the current draw ofthe motor 2448. The primary processor 2406 may utilize the signal fromthe motor current 2447 to control operation of the motor, for example,to ensure the current draw of the motor 2448 is within an acceptablerange, to compare the current draw of the motor 2448 to one or moreother parameters of the circuit 2400 such as, for example, the positionencoder 2440, and/or to determine one or more parameters of a treatmentsite. In some examples, the current monitor 2447 may be coupled to thesafety processor 2404.

In some aspects, actuation of one or more handle controls, such as, forexample, a firing trigger, causes the primary processor 2406 to decreasepower to one or more components while the handle control is actuated.For example, in one example, a firing trigger controls a firing strokeof a cutting member. The cutting member is driven by the motor 2448.Actuation of the firing trigger results in forward operation of themotor 2448 and advancement of the cutting member. During firing, theprimary processor 2406 closes the FET switch 2451 to remove power fromthe position encoder 2440. The deactivation of one or more circuitcomponents allows higher power to be delivered to the motor 2448. Whenthe firing trigger is released, full power is restored to thedeactivated components, for example, by closing the FET switch 2451 andreactivating the position encoder 2440.

In some aspects, the safety processor 2404 controls operation of thesegmented circuit 2400. For example, the safety processor 2404 mayinitiate a sequential power-up of the segmented circuit 2400, transitionof the segmented circuit 2400 to and from sleep mode, and/or mayoverride one or more control signals from the primary processor 2406.For example, in the illustrated example, the safety processor 2404 iscoupled to the step-down converter 2416. The safety processor 2404controls operation of the segmented circuit 2400 by activating ordeactivating the step-down converter 2416 to provide power to theremainder of the segmented circuit 2400.

FIG. 26 illustrates one aspect of a power system 2500 comprising aplurality of daisy chained power converters 2514, 2516, 2518 configuredto be sequentially energized. The plurality of daisy chained powerconverters 2514, 2516, 2518 may be sequentially activated by, forexample, a safety processor during initial power-up and/or transitionfrom sleep mode. The safety processor may be powered by an independentpower converter (not shown). For example, in one example, when a batteryvoltage V_(BATT) is coupled to the power system 2500 and/or anaccelerometer detects movement in sleep mode, the safety processorinitiates a sequential start-up of the daisy chained power converters2514, 2516, 2518. The safety processor activates the 13V boost section2518. The boost section 2518 is energized and performs a self-check. Insome examples, the boost section 2518 comprises an integrated circuit2520 configured to boost the source voltage and to perform a self check.A diode D prevents power-up of a 5V supply section 2516 until the boostsection 2518 has completed a self-check and provided a signal to thediode D indicating that the boost section 2518 did not identify anyerrors. In some examples, this signal is provided by the safetyprocessor. The examples, however, are not limited to the particularvoltage range(s) described in the context of this specification.

The 5V supply section 2516 is sequentially powered-up after the boostsection 2518. The 5V supply section 2516 performs a self-check duringpower-up to identify any errors in the 5V supply section 2516. The 5Vsupply section 2516 comprises an integrated circuit 2515 configured toprovide a step-down voltage from the boost voltage and to perform anerror check. When no errors are detected, the 5V supply section 2516completes sequential power-up and provides an activation signal to the3.3V supply section 2514. In some examples, the safety processorprovides an activation signal to the 3.3V supply section 2514. The 3.3Vsupply section comprises an integrated circuit 2513 configured toprovide a step-down voltage from the 5V supply section 2516 and performa self-error check during power-up. When no errors are detected duringthe self-check, the 3.3V supply section 2514 provides power to theprimary processor. The primary processor is configured to sequentiallyenergize each of the remaining circuit segments. By sequentiallyenergizing the power system 2500 and/or the remainder of a segmentedcircuit, the power system 2500 reduces error risks, allows forstabilization of voltage levels before loads are applied, and preventslarge current draws from all hardware being turned on simultaneously inan uncontrolled manner. The examples, however, are not limited to theparticular voltage range(s) described in the context of thisspecification.

In one aspect, the power system 2500 comprises an over voltageidentification and mitigation circuit. The over voltage identificationand mitigation circuit is configured to detect a monopolar returncurrent in the surgical instrument and interrupt power from the powersegment when the monopolar return current is detected. The over voltageidentification and mitigation circuit is configured to identify groundfloatation of the power system. The over voltage identification andmitigation circuit comprises a metal oxide varistor. The over voltageidentification and mitigation circuit comprises at least one transientvoltage suppression diode.

FIG. 27 illustrates one aspect of a segmented circuit 2600 comprising anisolated control section 2602. The isolated control section 2602isolates control hardware of the segmented circuit 2600 from a powersection (not shown) of the segmented circuit 2600. The control section2602 comprises, for example, a primary processor 2606, a safetyprocessor (not shown), and/or additional control hardware, for example,a FET Switch 2617. The power section comprises, for example, a motor, amotor driver, and/or a plurality of motor MOSFETS. The isolated controlsection 2602 comprises a charging circuit 2603 and a rechargeablebattery 2608 coupled to a 5V power converter 2616. The charging circuit2603 and the rechargeable battery 2608 isolate the primary processor2606 from the power section. In some examples, the rechargeable battery2608 is coupled to a safety processor and any additional supporthardware. Isolating the control section 2602 from the power sectionallows the control section 2602, for example, the primary processor2606, to remain active even when main power is removed, provides afilter, through the rechargeable battery 2608, to keep noise out of thecontrol section 2602, isolates the control section 2602 from heavyswings in the battery voltage to ensure proper operation even duringheavy motor loads, and/or allows for real-time operating system (RTOS)to be used by the segmented circuit 2600. In some examples, therechargeable battery 2608 provides a stepped-down voltage to the primaryprocessor, such as, for example, 3.3V. The examples, however, are notlimited to the particular voltage range(s) described in the context ofthis specification.

FIGS. 28A and 28B illustrate another aspect of a control circuit 3000configured to control the powered surgical instrument 10, illustrated inFIGS. 1-18A. As shown in FIGS. 18A, 28B, the handle assembly 14 mayinclude a motor 3014 which can be controlled by a motor driver 3015 andcan be employed by the firing system of the surgical instrument 10. Invarious forms, the motor 3014 may be a DC brushed driving motor having amaximum rotation of, approximately, 25,000 RPM, for example. In otherarrangements, the motor 3014 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. In certain circumstances, the motor driver 3015 maycomprise an H-Bridge FETs 3019, as illustrated in FIGS. 28A and 28B, forexample. The motor 3014 can be powered by a power assembly 3006, whichcan be releasably mounted to the handle assembly 14. The power assembly3006 is configured to supply control power to the surgical instrument10. The power assembly 3006 may comprise a battery which may include anumber of battery cells connected in series that can be used as thepower source to power the surgical instrument 10. In such configuration,the power assembly 3006 may be referred to as a battery pack. In certaincircumstances, the battery cells of the power assembly 3006 may bereplaceable and/or rechargeable. In at least one example, the batterycells can be Lithium-Ion batteries which can be separably couplable tothe power assembly 3006.

Examples of drive systems and closure systems that are suitable for usewith the surgical instrument 10 are disclosed in U.S. Provisional PatentApplication Ser. No. 61/782,866, entitled CONTROL SYSTEM OF A SURGICALINSTRUMENT, and filed Mar. 14, 2013, the entire disclosure of which isincorporated by reference herein in its entirety. For example, theelectric motor 3014 can include a rotatable shaft (not shown) that mayoperably interface with a gear reducer assembly that can be mounted inmeshing engagement with a set, or rack, of drive teeth on alongitudinally-movable drive member. In use, a voltage polarity providedby the battery can operate the electric motor 3014 to drive thelongitudinally-movable drive member to effectuate the end effector 300.For example, the motor 3014 can be configured to drive thelongitudinally-movable drive member to advance a firing mechanism tofire staples into tissue captured by the end effector 300 from a staplecartridge assembled with the end effector 300 and/or advance a cuttingmember to cut tissue captured by the end effector 300, for example.

As illustrated in FIGS. 28A and 28B and as described below in greaterdetail, the power assembly 3006 may include a power managementcontroller which can be configured to modulate the power output of thepower assembly 3006 to deliver a first power output to power the motor3014 to advance the cutting member while the interchangeable shaft 200is coupled to the handle assembly 14 (FIG. 1) and to deliver a secondpower output to power the motor 3014 to advance the cutting member whilethe interchangeable shaft assembly 200 is coupled to the handle assembly14, for example. Such modulation can be beneficial in avoidingtransmission of excessive power to the motor 3014 beyond therequirements of an interchangeable shaft assembly that is coupled to thehandle assembly 14.

In certain circumstances, the interface 3024 can facilitate transmissionof the one or more communication signals between the power managementcontroller 3016 and the shaft assembly controller 3022 by routing suchcommunication signals through a main controller 3017 residing in thehandle assembly 14 (FIG. 1), for example. In other circumstances, theinterface 3024 can facilitate a direct line of communication between thepower management controller 3016 and the shaft assembly controller 3022through the handle assembly 14 while the shaft assembly 200 (FIG. 1) andthe power assembly 3006 are coupled to the handle assembly 14.

In one instance, the main microcontroller 3017 may be any single core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one instance, the surgical instrument 10 (FIGS.1-4) may comprise a power management controller 3016 such as, forexample, a safety microcontroller platform comprising twomicrocontroller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments.Nevertheless, other suitable substitutes for microcontrollers and safetyprocessor may be employed, without limitation. In one instance, thesafety processor 2004 (FIG. 21A) may be configured specifically for IEC61508 and ISO 26262 safety critical applications, among others, toprovide advanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

In certain instances, the microcontroller 3017 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising on-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QEI) analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available for the productdatasheet. The present disclosure should not be limited in this context.

FIG. 29 is a block diagram the surgical instrument of FIG. 1illustrating interfaces between the handle assembly 14 (FIG. 1) and thepower assembly and between the handle assembly 14 and theinterchangeable shaft assembly. As shown in FIG. 29, the power assembly3006 may include a power management circuit 3034 which may comprise thepower management controller 3016, a power modulator 3038, and a currentsense circuit 3036. The power management circuit 3034 can be configuredto modulate power output of the battery 3007 based on the powerrequirements of the shaft assembly 200 (FIG. 1) while the shaft assembly200 and the power assembly 3006 are coupled to the handle assembly 14.For example, the power management controller 3016 can be programmed tocontrol the power modulator 3038 of the power output of the powerassembly 3006 and the current sense circuit 3036 can be employed tomonitor power output of the power assembly 3006 to provide feedback tothe power management controller 3016 about the power output of thebattery 3007 so that the power management controller 3016 may adjust thepower output of the power assembly 3006 to maintain a desired output.

It is noteworthy that the power management controller 3016 and/or theshaft assembly controller 3022 each may comprise one or more processorsand/or memory units which may store a number of software modules.Although certain modules and/or blocks of the surgical instrument 14(FIG. 1) may be described by way of example, it can be appreciated thata greater or lesser number of modules and/or blocks may be used.Further, although various instances may be described in terms of modulesand/or blocks to facilitate description, such modules and/or blocks maybe implemented by one or more hardware components, e.g., processors,Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs),Application Specific Integrated Circuits (ASICs), circuits, registersand/or software components, e.g., programs, subroutines, logic and/orcombinations of hardware and software components.

In certain instances, the surgical instrument 10 (FIGS. 1-4) maycomprise an output device 3042 which may include one or more devices forproviding a sensory feedback to a user. Such devices may comprise, forexample, visual feedback devices (e.g., an LCD display screen, LEDindicators), audio feedback devices (e.g., a speaker, a buzzer) ortactile feedback devices (e.g., haptic actuators). In certaincircumstances, the output device 3042 may comprise a display 3043 whichmay be included in the handle assembly 14 (FIG. 1). The shaft assemblycontroller 3022 and/or the power management controller 3016 can providefeedback to a user of the surgical instrument 10 through the outputdevice 3042. The interface 3024 can be configured to connect the shaftassembly controller 3022 and/or the power management controller 3016 tothe output device 3042. The reader will appreciate that the outputdevice 3042 can instead be integrated with the power assembly 3006. Insuch circumstances, communication between the output device 3042 and theshaft assembly controller 3022 may be accomplished through the interface3024 while the shaft assembly 200 is coupled to the handle assembly 14.

Having described a surgical instrument 10 (FIGS. 1-4) and variouscontrol circuits 2000, 3000 for controlling the operation thereof, thedisclosure now turns to various specific configurations of the surgicalinstrument 10 and control circuits 2000 (or 3000).

In various aspects the present disclosure provides techniques for datastorage and usage. In one aspect, data storage and usage is based onmultiple levels of action thresholds. Such thresholds include upper andlower ultimate threshold limits, ultimate threshold that shuts downmotor or activates return is current, pressure, firing load, torque isexceeded, and alternatively, while running within the limits the deviceautomatically compensates for loading of the motor.

In one aspect, the instrument 10 (described in connection with FIGS.1-29) can be configured to monitor upper and lower ultimate thresholdlimits to maintain minimum and maximum closure clamp loads withinacceptable limits. If a minimum is not achieved the instrument 10 cannotstart or if it drops below minimum a user action is required. If theclamp load is at a suitable level but drops under minimum during firing,the instrument 10 can adjust the speed of the motor or warn the user. Ifthe minimum limit is breached during operation the unit could give awarning that the firing may not be completely as anticipated. Theinstrument 10 also can be configured to monitor when the battery voltagedrops below the lower ultimate limit the remaining battery power is onlydirect able towards returning the device to the I-beam parked state. Theopening force on the anvil can be employed to sense jams in the endeffector. Alternatively, the instrument 10 can be configured to monitorwhen the motor current goes up or the related speed goes down, then themotor control increases pulse width or frequency modulation to keepspeed constant.

In another aspect, the instrument 10 can (FIG. 1) be configured todetect an ultimate threshold of current draw, pressure, firing load,torque such that when any of these thresholds are exceeded, theinstrument 10 shuts down the motor or causes the motor to return theknife to a pre-fired position. A secondary threshold, which is less thanthe ultimate threshold, may be employed to alter the motor controlprogram to accommodate changes in conditions by changing the motorcontrol parameters. A marginal threshold can be configured as a stepfunction or a ramp function based on a proportionate response to anothercounter or input. For example, in the case of sterilization, no changesbetween 0-200 sterilization cycles, slow motor 1% per use from 201-400sterilization cycles, and prevent use over 400 sterilization cycles. Thespeed of the motor also can be varied based on tissue gap and currentdraw.

There are many parameters that could influence the ideal function of apowered reusable stapler device. Most of these parameters have anultimate maximum and/or minimum threshold beyond which the device shouldnot be operated. Nevertheless, there are also marginal limits that mayinfluence the functional operation of the device. These multiple limits,from multiple parameters may provide an overlying and cumulative effecton the operations program of the device.

Accordingly, the present disclosure relates to surgical instruments and,in various circumstances, to surgical stapling and cutting instrumentsand staple cartridges therefor that are designed to staple and cuttissue.

Efficient performance of an electromechanical device depends on variousfactors. One is the operational envelope, i.e., range of parameters,conditions and events in which the device carries out its intendedfunctions. For example, for a device powered by a motor driven byelectrical current, there may be an operational region above a certainelectrical current threshold where the device runs more inefficientlythan desired. Put another way, there may be an upper “speed limit” abovewhich there is decreasing efficiency. Such an upper threshold may havevalue in preventing substantial inefficiencies or even devicedegradation.

There may be thresholds within an operational envelope, however, thatmay form regions exploitable to enhance efficiency within operationalstates. In other words, there may be regions where the device can adjustand perform better within a defined operational envelope (orsub-envelope). Such a region can be one between a marginal threshold andan ultimate threshold. In addition, these regions may comprise “sweetspots” or a predetermined optional range or point. These regions alsomay comprise a large range within which performance is judged to beadequate.

An ultimate threshold can be defined, above which or below which anaction or actions could be taken (or refrained from being taken) such asstopping the device. In addition, a marginal threshold or thresholds canbe defined, above which or below which an action or actions could betaken (or refrained from being taken). By way of non-limiting example, amarginal threshold can be set to define where the current draw of themotor exceeds 75% of an ultimate threshold. Exceeding the marginalthreshold can result, for example, in the device's beginning to slowmotor speed at an increasing rate as it continues to climb toward theultimate threshold.

Various mechanisms can be employed to carry out the adjustment(s) takenas a result of exceeding a threshold. For example, the adjustment canreflect a step function. It can also reflect a ramped function. Otherfunctions can be utilized.

In various aspects, to enhance performance by additional mechanisms, anoverlaying threshold can be defined. An overlaying threshold cancomprise one or more thresholds defined by multiple parameters. Anoverlaying threshold can result in one or more thresholds being an inputinto the generation of another threshold or thresholds. An overlayingthreshold can be predetermined or dynamically generated such as atruntime. The overlaying threshold may come into effect when you thethreshold is defined by multiple inputs. For example, as the number ofsterilization cycles exceeds 300 (the marginal threshold) but not 500(the ultimate threshold) the device runs the motor slower. Then as thecurrent draw exceeds its 75% marginal threshold it multiples the slowdown going even slower.

FIG. 30 is a logic diagram disclosing aspects of a multiple-levelthreshold system wherein a threshold rules framework 4000. Parameterscan be identified 4010, such parameters representing quantities,amounts, states, events or more. For example, parameters identified caninclude one or more of current, voltage, tissue pressure, tissuethickness, jaw closure rate, tissue creep rate, firing load, knifethickness, torque, or battery usage. An ultimate threshold or thresholdsfor these parameters can be identified 4012. For instance, apredetermined current draw can be identified. As but one example, anultimate electrical current draw threshold may be defined as 100% of aselected current magnitude. There can be an upper ultimate threshold, alower ultimate threshold, multiple lower or upper ultimate thresholdsdepending on the circumstances, or a range defining an ultimatethreshold. It will be appreciated that an “ultimate” threshold can bedefined and/or calibrated in such a way as to remain essentially aunitary threshold but embody various action triggers. A marginalthreshold or thresholds can be identified 4014. If the marginalthreshold is exceeded, a motor control program can alter operations toaccommodate change.

One or more thresholds can be monitored an acted on during a singlesurgical procedure, wherein the thresholds are independent of each otherwith no interaction. In addition, there can be an interactiveassociation between thresholds of two or more parameters. For example, amarginal threshold for a parameter based on current draw can be 75% ofthe ultimate threshold. In addition, in connection with a parameterbased on number of sterilization cycles, a marginal threshold may be setat 200 sterilization cycles, and an ultimate threshold at sterilization400 cycles. Motor use can proceed normally from 0-199 cycles, and thenslow by 1% from 200 cycles to 399. At cycle 400, motor use can beprevented. It will be appreciated, however, that there can be aninteractive effect. In other words, because motor speed is reduced by 1%due to exceeding the sterilization cycle threshold, the current drawthreshold can be correspondingly adjusted. This interactive effect canresult in the motor running more slowly than it would if either inputwere considered independently.

Thus, the value of one threshold can be an input into the value ofanother threshold, or one threshold can be completely independent ofanother threshold. Where two or more thresholds are activated, it can beconsidered that there can be an overlaying threshold. As a result,multiple thresholds, defining multiple boundaries and limits, can havean overlaying or cumulative effect on operations of instrument 10 (FIGS.1-4). And, one threshold in a multiple-threshold operation scenario canhave a cause-and-effect with another threshold, or there may be nocause-and-effect and the thresholds may exist independent of each other.

In addition, a threshold can be dynamically set and/or reset dependingon conditions experienced during surgery or other conditions. In otherwords, prior to a given surgical procedure, a module or modules can bepreprogrammed into instrument 10 (FIGS. 1-4) or uploaded as needed.Also, a threshold can be dynamically determined, or uploaded, during asurgical procedure.

Turning briefly now to FIG. 1, numerous parameters can be assignedthresholds. Thus, in examples thresholds may be assigned based on tissuegap between the anvil 306 and staple cartridge 304, or anvil 306 andsecond jaw member 302, of an end effector 300, and motor speed variedthereby. In addition, in example thresholds based on current can varymotor speed control. Further, in various examples ultimate, marginal andoverlaying thresholds can be established in connection with closureclamp loads in furtherance of an acceptable operating range. Plus, invarious examples opening force on an anvil 306 can help to detect a jam.Further, in various examples if a minimum threshold is not achieved, thesystem may be prevented from starting or if it drops below a minimumthen a user action can be required.

Still with reference to FIG. 1, in various aspects, it can be determinedwhether clamp load is acceptable and when clamp load drops under aminimum threshold during firing the speed of the motor can be adjustedand/or the clinician warned. In various examples, when a minimumthreshold is exceeded during operation, instrument 10 can give a warningthat the firing may not be completely as anticipated. Moreover, invarious examples thresholds can be assigned wherein if battery chargefalls below a threshold then remaining battery charge can be used toreturn the device to a parked state with respect to the I-beam.

However, thresholds can be referenced even during operations that do notexceed a threshold. Thus, for example, instrument 10 can, while running“within limits”, compensate for the loading of the motor. For instance,if current goes up or related speed goes down, then motor control canincrease pulse width or frequency modulation to help to maintain aconstant speed. In other words, measures can be taken to improve and/oroptimize operations of instrument 10 even while running “within limits.”

In addition, dynamically during a surgical procedure, a threshold can bemodified, or a new threshold generated. This can occur after severalevents including adjusting operations of the instrument 10.

Turning now back to FIG. 30, in various aspects a parameter orparameters are identified 4010. Further, an ultimate threshold orthresholds for a given parameter(s) are identified 4012. In addition, amarginal threshold or thresholds for a given parameter(s) are identified4014. Measures 4010, 4012, and 4014 can be accomplished prior to theprocedure, during the procedure, or both.

Measurements of a parameter(s) are obtained 4016. It can be determinedwhether the measurement of a given parameter exceeds an upper or lowerultimate threshold for the parameter 4018. When the answer is no, it canbe determined whether the measurement of a given parameter exceeds anupper or lower marginal threshold for the parameter 4020. When theanswer is no, operations can be continued 4026. And, measurements of agiven parameter(s) can be again obtained.

When, however, the answer is yes to whether the measurement of a givenparameter exceeds an upper or lower ultimate threshold for the parameter4018, control can pass to where operations can be adjusted 4022. Manytypes of adjustments can be made. One example is to vary motor speed. Itcan be determined whether to modify a given threshold and/or generate anew threshold 4024. This can occur after operations have been adjusted4022.

After operations are adjusted, it can be determined whether to modify athreshold or generate a new threshold. For example, a marginal thresholdinitially set at 75% can be set to a different value. In addition, a newthreshold on the same parameter, or a new threshold on a new parameter,can be generated if desired.

Upon determining whether to modify a threshold or generate a new one,control can pass back to step 4016 where measurement of a parameter(s)is obtained. In addition, control can proceed to identify 4010parameters.

When the answer to whether the measurement exceeds an upper or lowerultimate threshold is no, however, then it can be determined when themeasurement exceeds an upper or lower marginal threshold. When theanswer is yes, then operations can be adjusted 4022 and control proceedas above. When the answer is no, operations can be continued 4026 andcontrol proceed to measuring a parameter(s).

It will be appreciated that the sequence of steps can be varied and isnot limited to that specifically disclosed in FIG. 30. As just oneexample, after obtaining measurement of a parameter(s) 4016, it can thenbe determined whether a marginal threshold is exceeded 4020. Inaddition, an overlaying threshold can expressly be identified andconsidered in the course of the flow.

FIG. 31 is a graphical representation 4100 of instrument systemparameters versus time depicting how, in one aspect, instrument systemparameters can be adjusted in the event that a threshold is reached.Time (t) is shown along a horizontal (x) axis 4102 and the instrumentSystem Parameter is shown along a vertical (y) axis 4104, marginalthreshold 4104 and ultimate threshold 4106. In the graphicalrepresentation 4100 depicted in FIG. 34, the y-axis parameter 4102 isthe one to which a threshold of instrument system parameter is assignedand the x-axis 4102 represents time. At a certain time during operationof instrument 10 (FIGS. 1-4), as evidenced by function 4110, ameasurement can indicate that marginal threshold 4106 is reached. Atthis point, operations of the instrument 10 (FIGS. 1-4) can be adjusted.For example, when the y-axis 4104 parameter is electrical current drawby a motor, a function can be imposed on the subsequent electricalcurrent draw and limit current in some fashion. In one example, thefunction can represent a linear progression 4112. At a certain time inthe course of operation, an ultimate threshold 4108 can be reached. Atthis point, electrical current can be discontinued 4114. Accordingly, anadjustment mechanism can be accomplished via a linear function. Anadditional perspective with which to view the operational adjustment isthat there can be a square-wave multiplier change.

FIG. 32 is a graphical representation 4120 of instrument systemparameter depicting how, in another aspect, a system parameter can beadjusted in the event that a threshold is reached. Time (t) is shownalong a horizontal (x) axis 4122 and the number of Instrument Operationsis shown along a vertical (y) axis 4124, marginal threshold 4126 andultimate threshold 4128. Here the y-axis 4124 parameter is the one towhich a threshold is assigned. At a certain time during operation ofinstrument 10 (FIGS. 1-4), a measurement can indicate that the marginalthreshold 4126 is reached during the course of operation 4130. At thispoint, operations of the instrument 10 can be adjusted. For example,when the y-axis 4124 parameter is electrical current draw by a motor, alimit can be placed on the subsequent current draw representing anon-linear progression 4132. At a certain time after this, an ultimatethreshold 4128 can be reached. At this point, current can bediscontinued 4134. Accordingly, an adjustment mechanism can beaccomplished via a non-linear function 4132, with a variable slope. Anadditional perspective with which to view the operational adjustment isthat there is an exponential multiplier change; here, the closer they-axis 4124 parameter comes to the ultimate threshold 4128, the rate atwhich current increases diminishes.

FIG. 33 is a graphical representation 4140 that represents one aspectwherein a response by instrument 10 (FIGS. 1-4) to clinician input (UserInput) is detected and then a modification is made. Time (t) is shownalong a horizontal (x) axis 4142 and User Input is represented along avertical (y) axis 4144. In other words, a clinician, in performing aprocedure, can actuate a response by instrument 10 such as depressingclosure trigger 32 (FIG. 1) which may for example cause motor operation4146. As motor speed increases there may or not be a threshold reached.At a certain point, however, here represented by the divergence point4148 of curves 4150 and 4152, it can be determined that motor speed hasreached an actual level, or a future level be predicted, that is or willbe suboptimal or otherwise undesirable. At this point, rather thanfollowing the actual or expected speed curve 4150, instrument 10 canemploy a control measure such as an algorithm to adapt or otherwisemodify the output, thus regulating the motor. At a certain point, motoractuation can be discontinued 4154. In other words, instrument 10 cantake an actual or expected y-axis parameter and, determining that suchactual or expected measurement is excessive, employ an algorithm tomodify such parameter. Put another way, measured clinician behavior cancomprise a value for a threshold or thresholds.

FIG. 34 is a graphical representation 4160 of instrument systemparameters that represents one aspect wherein instrument 10 (FIGS. 1-4)detects whether a marginal threshold 4166 or ultimate threshold 4168 isreached, and responds accordingly. Time (t) is shown along thehorizontal (x) axis 4162 and instrument System Parameters is shown alongthe vertical (y) axis 4164. For example, here the vertical (y) axis 4154parameter can be the velocity of a drive, such as a closure drive system30 (FIG. 1) or firing drive system 80 (FIG. 1). Instrument 10 can checkwhether during the course of operation 4170 a marginal threshold 4166velocity is reached. When the marginal threshold 4166 is reached, acontrol measure such as an algorithm can be used to adapt or otherwisemodify the velocity 4172. The modified velocity 4172 can be given by alinear or non-linear function. And, at an ultimate threshold, power tothe motor can be discontinued 4174.

It will be appreciated that where FIG. 33 can represent a situationwhere an actual or predicted value is evaluated, whether or not anexpress threshold is provided, FIG. 34 is a graphical representationwhere thresholds are provided. It can be appreciated, however, that athreshold or thresholds can be implicitly given to FIG. 33 withequivalent results, insofar as a predetermined or dynamically determinedvalue can serve as a functional equivalent of a threshold, or triggeractions associated with a threshold or thresholds. There may be two ormore ceiling or floor values that can serve as such threshold functionalequivalents.

Turning to another example using thresholds, FIG. 35 is a graphicalrepresentation 4180 of battery current versus time, where Time (t) isshown along the horizontal (x) axis 4182 and battery current I_(BAT) isshown along the vertical (y) axis 4184. In one example battery currentI_(BAT) 4184 is monitored under varying operational conditions. As motorspeed increases, current drawn 4186 from a battery 90 (FIG. 4)increases. Current drawn can increase in a non-linear manner dependingon several factors; however, instrument 10 (FIGS. 1-4) can resolve thecurrent drawn into a linear function 4188. The linear function can bebased on (1) averaging overall current, (2) be based on a prediction offuture current based on past and/or present current, both (1) and (2),or another function. Linear function 4188 can be extended outtheoretically to linear function 4190, which is an extrapolatedextension with the same slope as linear function 4188.

Once linear function 4188 reaches a marginal threshold 4192, instrument10 (FIGS. 1-4) can take action to modify the response. Here the marginalthreshold is given as 75% of an ultimate threshold 4194 wherein theultimate threshold represents a motor stall; however, it will beappreciated that the selection of the marginal threshold or ultimatethreshold can be made based on multiple factors. In other words,marginal threshold 4192 can be reached at time “a” 4196. If adjustmentsare not made, it is expected that motor stall would occur at time “b1”4198. However, due to adjustments made by instrument 10, the actualmotor stall will not occur until time “b2” 4200. It is possible that astall might not occur at all, because the more graduated rise may helpto prevent such an event. Function 4202, which is implemented via acontrol measure, can be based on slowing the motor, or anotheradjustment. It can manifest as a stepped, ramped or further function.

Employing the thresholds herein can give the clinician greater time toreact and adapt, maintain a desired efficiency of the instrument, andprolong battery life. Thus, utilizing thresholds can provide multiplebenefits in connection with ease of clinician use and protection of theinstrument itself.

Turning to another aspect, FIG. 36 is a graphical representation 4210 ofbattery voltage that shows Time (t) along the horizontal (x) axis 4212and battery voltage V_(BAT) along the vertical (y) axis 4214. In oneexample a threshold can be set in connection with battery voltageV_(BAT) 4214. Here a marginal threshold 4216 can be set at 8.1V.Additionally, an ultimate threshold 4218 can be set at 7.0V. During thecourse of operation of instrument 10 (FIGS. 1-4), voltage can decreaseover time. The curve described by measuring the voltage decrease 4220 isnot necessarily linear. However, instrument 10 can resolve the voltagedecrease into a linear function 4222. The linear function can be basedon (1) averaging overall voltage, (2) be based on a prediction of futurevoltage based on past and/or present voltage, both (1) and (2), oranother function. Linear function 4222 can be extrapolated outtheoretically to linear function 4224, which has the same slope aslinear function 4222.

Once linear function 4222 reaches a marginal threshold 4216, instrument10 can take action to modify the response. Marginal threshold 4216 isreached at time “a” 4226. If adjustments are not made, it is expectedthat a depleted battery condition would occur at time “b1” 4228.However, due to adjustments made by instrument 10 (FIGS. 1-4), theactual depleted battery condition will not occur until time “b2” 4230.Again, it is possible that it may not occur at all. Function 4232, whichcan be implemented via a control measure, can be based on slowing themotor, or another adjustment. It can manifest as a stepped, ramped orfurther function.

FIG. 37 is a graphical representation 4240 of knife speed versus numberof cycles where and Cycles is shown along the horizontal (x) axis 4242and Knife Speed is shown along the vertical (y) axis 4244. As shown inthe example illustrated by FIG. 37, thresholds can be employed to adjustspeed of a knife 280 (FIG. 8) based on the number of cycles. Relevantcycles can refer to an amount of firings performed by instrument 10(FIGS. 1-4), sterilization cycles performed by instrument 10, or othermeasured events. An objective of managing instrument operation by thisthreshold mechanism is to maximize the likelihood that an incision willbe effective, taking into account potential blunting of the knife 280edge after multiple uses. In this example, firing of the knife can beinitialized based on an expected speed. However, once a marginalthreshold 4246 is reached based on number of cycles, speed can bereduced from speed 4248 to 4252, such as in a stepped manner 4250. Thus,once marginal threshold 4760 is exceeded, knife 280 will fire at aprogressively lower speed. This will occur for a given number of cycles4246 until ultimate threshold 4254 is reached. At this point, knifespeed will be stepped down 4256 even more or of course instrument 10 canalert the clinician that it may be undesirable to incise with the knife,and can lock out firing. It will be understood that function 4248 showsemploying a stepped function once a threshold 4246 is reached, andfunction 4258 shows employing a ramped function 4260 once a threshold4246 is reached. Additional functions can be employed.

Further, it will be appreciated that the thresholds given in FIG. 37have been defined on the x-axis 4711, whereas prior figures have shownthresholds on the y-axis 4712. It will also be appreciated that therecan be an additional axis or axes taken into account, i.e., a z-axis orfurther axes, wherein the interrelationship of multiple variables can beconsidered. Further, thresholds from a first parameter can be consideredalong with thresholds from a second parameter, and one threshold cancomprise an input into another threshold, and vice versa.

When a threshold is exceeded, the clinician can be notified. This can bebased on a feedback system. In certain instances, the feedback systemmay comprise one or more visual feedback systems such as displayscreens, backlights, and/or LEDs, for example. In certain instances, thefeedback system may comprise one or more audio feedback systems such asspeakers and/or buzzers, for example. In certain instances, the feedbacksystem may comprise one or more haptic feedback systems, for example. Incertain instances, the feedback system may comprise combinations ofvisual, audio, and/or tactile feedback systems, for example. Suchfeedback can serve to alert or warn the clinician.

FIG. 38 illustrates a logic diagram of a system 4311 for evaluatingsharpness of a cutting edge 182 (FIG. 20) of a surgical instrument 10(FIGS. 1-4) according to various examples. FIG. 38 illustrates asharpness testing system 4311 for evaluating sharpness of a cutting edgeof a surgical instrument 10 according to various examples. In certaininstances, the system 4311 can evaluate the sharpness of the cuttingedge 182 by testing the ability of the cutting edge 182 to be advancedthrough a sharpness testing member 4302. For example, the system 4311can be configured to observe the time period the cutting edge 182 takesto fully transect and/or completely pass through at least apredetermined portion of a sharpness testing member 4302. If theobserved time period exceeds a predetermined threshold, the module 4310may conclude that the sharpness of the cutting edge 182 has droppedbelow an acceptable level, for example.

In one aspect, the sharpness testing member 4302 can be employed to testthe sharpness of the cutting edge 182 (FIG. 20). In certain instances,the sharpness testing member 4302 can be attached to and/or integratedwith the cartridge body 194 (FIG. 20) of the staple cartridge 304 (FIGS.1, 2, and 20), for example. In certain instances, the sharpness testingmember 4302 can be disposed in the proximal portion of the staplecartridge 304, for example. In certain instances, the sharpness testingmember 4302 can be disposed onto a cartridge deck or cartridge body 194of the staple cartridge 304, for example.

In certain instances, a load cell 4335 can be configured to monitor theforce (Fx) applied to the cutting edge 182 (FIG. 20) while the cuttingedge 182 is engaged and/or in contact with the sharpness testing member4302, for example. The reader will appreciate that the force (Fx)applied by the sharpness testing member 4302 to the cutting edge 182while the cutting edge 182 is engaged and/or in contact with thesharpness testing member 4302 may depend, at least in part, on thesharpness of the cutting edge 182. In certain instances, a decrease inthe sharpness of the cutting edge 182 can result in an increase in theforce (Fx) required for the cutting edge 182 to cut or pass through thesharpness testing member 4302. The load cell 4335 of the sharpnesstesting member 4302 may be employed to measure the force (Fx) applied tothe cutting edge 182 while the cutting edge 182 travels a predefineddistance (D) through the sharpness testing member 4302 may be employedto determine the sharpness of the cutting edge 182.

In certain instances, the module 4311 may include a microcontroller 4313(“controller”) which may include a microprocessor 4315 (“processor”) andone or more computer readable mediums or memory units 4317 (“memory”).In certain instances, the memory 4317 may store various programinstructions, which when executed may cause the processor 4315 toperform a plurality of functions and/or calculations described herein.In certain instances, the memory 4317 may be coupled to the processor4315, for example. A power source 4319 can be configured to supply powerto the controller 4313, for example. In certain instances, the powersource 4319 may comprise a battery (or “battery pack” or “power pack”),such as a Li ion battery, for example. In certain instances, the batterypack may be configured to be releasably mounted to the handle 14. Anumber of battery cells connected in series may be used as the powersource 4319. In certain instances, the power source 4319 may bereplaceable and/or rechargeable, for example.

In certain instances, the processor 4313 can be operably coupled to thefeedback system and/or the lockout mechanism 4123, for example.

The module 4311 may comprise one or more position sensors. Exampleposition sensors and positioning systems suitable for use with thepresent disclosure are described in U.S. patent application Ser. No.13/803,210, entitled SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEMFOR SURGICAL INSTRUMENTS, and filed Mar. 14, 2013, now U.S. PatentApplication Publication No. 2014/0263538, the disclosure of which ishereby incorporated by reference herein in its entirety. In certaininstances, the module 4311 may include a first position sensor 4321 anda second position sensor 4323. In certain instances, the first positionsensor 4321 can be employed to detect a first position of the cuttingedge 182 (FIG. 20) at a proximal end of a sharpness testing member 4302,for example; and the second position sensor 4323 can be employed todetect a second position of the cutting edge 182 at a distal end of asharpness testing member 4302, for example.

In certain instances, the position sensors 4321 and 4323 can be employedto provide first and second position signals, respectively, to themicrocontroller 4313. It will be appreciated that the position signalsmay be analog signals or digital values based on the interface betweenthe microcontroller 4313 and the position sensors 4321 and 4323. In oneexample, the interface between the microcontroller 4313 and the positionsensors 4321 and 4323 can be a standard serial peripheral interface(SPI), and the position signals can be digital values representing thefirst and second positions of the cutting edge 182, as described above.

Further to the above, the processor 4315 may determine the time periodbetween receiving the first position signal and receiving the secondposition signal. The determined time period may correspond to the timeit takes the cutting edge 182 (FIG. 20) to advance through a sharpnesstesting member 4302 from the first position at a proximal end of thesharpness testing member 4302, for example, to a second position at adistal end of the sharpness testing member 4302, for example. In atleast one example, the controller 4313 may include a time element whichcan be activated by the processor 4315 upon receipt of the firstposition signal, and deactivated upon receipt of the second positionsignal. The time period between the activation and deactivation of thetime element may correspond to the time it takes the cutting edge 182 toadvance from the first position to the second position, for example. Thetime element may comprise a real time clock, a processor configured toimplement a time function, or any other suitable timing circuit.

In various instances, the controller 4313 can compare the time period ittakes the cutting edge 182 (FIG. 20) to advance from the first positionto the second position to a predefined threshold value to assess whetherthe sharpness of the cutting edge 182 has dropped below an acceptablelevel, for example. In certain instances, the controller 4313 mayconclude that the sharpness of the cutting edge 182 has dropped below anacceptable level if the measured time period exceeds the predefinedthreshold value by 1%, 5%, 10%, 25%, 50%, 100% and/or more than 100%,for example.

FIG. 39 illustrates a logic diagram of a system 4340 for determining theforces applied against a cutting edge of a surgical instrument 10 (FIGS.1-4) by a sharpness testing member 4302 at various sharpness levelsaccording to various aspects. Referring to FIG. 39, in variousinstances, an electric motor 4331 can drive the firing bar 172 (FIG. 20)to advance the cutting edge 182 (FIG. 20) during a firing stroke and/orto retract the cutting edge 182 during a return stroke, for example. Amotor driver 4333 can control the electric motor 4331; and amicrocontroller such as, for example, the microcontroller 4313 can be insignal communication with the motor driver 4333. As the electric motor4331 advances the cutting edge 182, the microcontroller 4313 candetermine the current drawn by the electric motor 4331, for example. Insuch instances, the force required to advance the cutting edge 182 cancorrespond to the current drawn by the electric motor 4331, for example.Referring still to FIG. 39, the microcontroller 4313 of the surgicalinstrument 10 can determine if the current drawn by the electric motor4331 increases during advancement of the cutting edge 182 and, if so,can calculate the percentage increase of the current.

In certain instances, the current drawn by the electric motor 4331 mayincrease significantly while the cutting edge 182 (FIG. 20) is incontact with the sharpness testing member 4302 due to the resistance ofthe sharpness testing member 4302 to the cutting edge 182. For example,the current drawn by the electric motor 4331 may increase significantlyas the cutting edge 182 engages, passes and/or cuts through thesharpness testing member 4302. The reader will appreciate that theresistance of the sharpness testing member 4302 to the cutting edge 182depends, in part, on the sharpness of the cutting edge 182; and as thesharpness of the cutting edge 182 decreases from repetitive use, theresistance of the sharpness testing member 4302 to the cutting edge 182will increase. Accordingly, the value of the percentage increase of thecurrent drawn by the motor 4331 while the cutting edge is in contactwith the sharpness testing member 4302 can increase as the sharpness ofthe cutting edge 182 decreases from repetitive use, for example.

In certain instances, the determined value of the percentage increase ofthe current drawn by the motor 4331 can be the maximum detectedpercentage increase of the current drawn by the motor 4331. In variousinstances, the microcontroller 4313 can compare the determined value ofthe percentage increase of the current drawn by the motor 4331 to apredefined threshold value of the percentage increase of the currentdrawn by the motor 4331. If the determined value exceeds the predefinedthreshold value, the microcontroller 4313 may conclude that thesharpness of the cutting edge 182 has dropped below an acceptable level,for example.

In certain instances, as illustrated in FIG. 39, the processor 4315 canbe in communication with the feedback system and/or the lockoutmechanism for example. In certain instances, the processor 4315 canemploy the feedback system to alert a user if the determined value ofthe percentage increase of the current drawn by the motor 4331 exceedsthe predefined threshold value, for example. In certain instances, theprocessor 4315 may employ the lockout mechanism to prevent advancementof the cutting edge 182 (FIG. 20) if the determined value of thepercentage increase of the current drawn by the motor 4331 exceeds thepredefined threshold value, for example. In certain instances, thesystem 4311 may include a first position sensor 4321 and a secondposition sensor 4323. The surgical instrument 10 (FIGS. 1-4) may includea load cell 4335.

In various instances, the microcontroller 4313 can utilize an algorithmto determine the change in current drawn by the electric motor 4331. Forexample, a current sensor can detect the current drawn by the electricmotor 4331 during the firing stroke. The current sensor can continuallydetect the current drawn by the electric motor and/or can intermittentlydetect the current draw by the electric motor. In various instances, thealgorithm can compare the most recent current reading to the immediatelyproceeding current reading, for example. Additionally or alternatively,the algorithm can compare a sample reading within a time period X to aprevious current reading. For example, the algorithm can compare thesample reading to a previous sample reading within a previous timeperiod X, such as the immediately proceeding time period X, for example.In other instances, the algorithm can calculate the trending average ofcurrent drawn by the motor. The algorithm can calculate the averagecurrent draw during a time period X that includes the most recentcurrent reading, for example, and can compare that average current drawto the average current draw during an immediately proceeding time periodtime X, for example.

FIG. 40 illustrates a logic diagram 4350 of a method for determiningwhether a cutting edge of a surgical instrument 10 (FIGS. 1-4) issufficiently sharp to transect tissue captured by the surgicalinstrument 10 according to various aspects. Referring to FIG. 40, thelogic diagram 4350 depicts a method for evaluating the sharpness of thecutting edge 182 (FIG. 20) of the surgical instrument 10; and variousresponses are outlined in the event the sharpness of the cutting edge182 drops to and/or below an alert threshold and/or a high severitythreshold, for example. In various instances, a microcontroller such as,for example, the microcontroller 4313 can be configured to implement themethod 4350 depicted in FIG. 40. In certain instances, the surgicalinstrument 10 may include a load cell 4335, as illustrated in FIGS. 38and 39, and the microcontroller 4313 may be in communication with theload cell 4335. In certain instances, the load cell 4335 may include aforce sensor such as, for example, a strain gauge, which can be operablycoupled to the firing bar 172, for example. In certain instances, themicrocontroller 4313 may employ the load cell 4335 to monitor the force(Fx) applied to the cutting edge 182 as the cutting edge 182 is advancedduring a firing stroke.

In various instances, the method 4350 begins by initiating 4352 firingof the surgical instrument 10 (FIGS. 1-4). Before, during, and/or afterfiring of the surgical instrument 10 is initiated 4352, a system checks4354 the dullness of the cutting edge 182 by monitoring a force (Fx).The reader will appreciate that the force (Fx) is applied by thesharpness testing member 4302 to the cutting edge 182 while the cuttingedge 182 is engaged and/or in contact with the sharpness testing member4302, and, the force (Fx) may depend, at least in part, on the sharpnessof the cutting edge 182. In certain instances, a decrease in thesharpness of the cutting edge 182 can result in an increase in the force(Fx) required for the cutting edge 182 to cut or pass through thesharpness testing member 4302.

The system senses 4356 the force (Fx) applied by the sharpness testingmember 4302 to the cutting edge 182 (FIG. 20). When the force (Fx)sensed 4356 stays within an alert threshold range a display will display4358 nothing and firing 4360 of the surgical instrument 10 (FIGS. 1-4)will proceed. When the force (Fx) sensed 4356 is outside the alertthreshold range, the system 4354 will then determine if the force (Fx)is outside a high severity threshold range. The display will display4364 an alert to the user of the surgical instrument 10 that the cuttingedge 182 is dulling. At this stage, the user is aware that the cuttingedge 182 is dulling and may need replaced. When the force (Fx) is sensed4362 to be greater than the high severity threshold range, the displaydisplays 4366 a warning indicating the force (Fx) applied to the cuttingedge 182 is greater than the high severity threshold and that thecutting edge 182 is dull. If the cutting edge is determined to be dull,a firing lockout system may be engaged. The display may display 4368 anoptional display sequence to allow the user of the surgical instrument10 to override the firing lockout system and continue firing 4360 thissurgical instrument 10.

In certain instances, the load cell 4335 (FIGS. 38, 39) can beconfigured to monitor the force (Fx) applied to the cutting edge 182(FIG. 20) while the cutting edge 182 is engaged and/or in contact withthe sharpness testing member 4302 (FIGS. 38, 39), for example. Thereader will appreciate that the force (Fx) applied by the sharpnesstesting member 4302 to the cutting edge 182 while the cutting edge 182is engaged and/or in contact with the sharpness testing member 4302 maydepend, at least in part, on the sharpness of the cutting edge 182. Incertain instances, a decrease in the sharpness of the cutting edge 182can result in an increase in the force (Fx) required for the cuttingedge 182 to cut or pass through the sharpness testing member 4302. Forexample, as illustrated graphically in FIG. 41, graphs 4336, 4338, and4342 represent, respectively, the force (Fx) applied to the cutting edge182 while the cutting edge 182 travels a predefined distance (D) throughthree identical, or at least substantially identical, sharpness testingmembers 4302. The graph 4336 corresponds to a first sharpness of thecutting edge 182; the graph 4338 corresponds to a second sharpness ofthe cutting edge 182; and the graph 4342 corresponds to a thirdsharpness of the cutting edge 182. The first sharpness is greater thanthe second sharpness, and the second sharpness is greater than the thirdsharpness.

In certain instances, the microcontroller 4313 (FIGS. 38, 39) maycompare a maximum value of the monitored force (Fx) applied to thecutting edge 182 (FIG. 20) to one or more predefined threshold values.In certain instances, as illustrated in FIG. 41, the predefinedthreshold values may include an alert threshold (F1) and/or a highseverity threshold (F2). In certain instances, as illustrated in thegraph 4336 of FIG. 41, the monitored force (Fx) can be less than thealert threshold (F1), for example. In such instances, as illustrated inFIG. 41, the sharpness of the cutting edge 182 is at a good level andthe microcontroller 4313 may take no action to alert a user as to thestatus of the cutting edge 182 or may inform the user that the sharpnessof the cutting edge 182 is within an acceptable range.

In certain instances, as illustrated in the graph 4338 of FIG. 41, themonitored force (Fx) can be more than the alert threshold (F1) but lessthan the high severity threshold (F2), for example. In such instances,as illustrated in FIG. 40, the sharpness of the cutting edge 182 (FIG.2) can be dulling but still within an acceptable level. Themicrocontroller 4313 may take no action to alert a user as to the statusof the cutting edge 182. Alternatively, the microcontroller 4313 (FIGS.38, 39) may inform the user that the sharpness of the cutting edge 182is within an acceptable range. Alternatively or additionally, themicrocontroller 4313 may determine or estimate the number of cuttingcycles remaining in the lifecycle of the cutting edge 182 and may alertthe user accordingly.

In certain instances, the memory 4317 (FIGS. 38, 39) may include adatabase or a table that correlates the number of cutting cyclesremaining in the lifecycle of the cutting edge 182 (FIG. 20) topredetermined values of the monitored force (Fx). The processor 4315(FIGS. 38, 39) may access the memory 4317 to determine the number ofcutting cycles remaining in the lifecycle of the cutting edge 182 whichcorrespond to a particular measured value of the monitored force (Fx)and may alert the user to the number of cutting cycles remaining in thelifecycle of the cutting edge 182, for example.

In certain instances, as illustrated in the graph 4342 of FIG. 41, themonitored force (Fx) can be more than the high severity threshold (F2),for example. In such instances, as illustrated in FIG. 40, the sharpnessof the cutting edge 182 can be below an acceptable level. In response,the microcontroller 4313 may employ the feedback system to warn the userthat the cutting edge 182 is too dull for safe use, for example. Incertain instances, the microcontroller 4313 may employ the lockoutmechanism to prevent advancement of the cutting edge 182 upon detectionthat the monitored force (Fx) exceeds the high severity threshold (F2),for example. In certain instances, the microcontroller 4313 may employthe feedback system to provide instructions to the user for overridingthe lockout mechanism, for example.

Referring now to FIG. 42, a method 4370 is depicted for determiningwhether a cutting edge such as, for example, the cutting edge 182 (FIG.20) is sufficiently sharp to be employed in transecting a tissue of aparticular tissue thickness that is captured by the end effector 300(FIG. 1), for example. In certain instances, the microcontroller 4313can be implemented to perform the method 4370 depicted in FIG. 42, forexample. As described above, repetitive use of the cutting edge 182 maydull or reduce the sharpness of the cutting edge 182 which may increasethe force required for the cutting edge 182 to transect the capturedtissue. In other words, the sharpness level of the cutting edge 182 canbe defined by the force required for the cutting edge 182 to transectthe captured tissue, for example. The reader will appreciate that theforce required for the cutting edge 182 to transect a captured tissuealso may depend on the thickness of the captured tissue. In certaininstances, the greater the thickness of the captured tissue, the greaterthe force required for the cutting edge 182 to transect the capturedtissue at the same sharpness level, for example.

In certain instances, the cutting edge 182 (FIG. 20) may be sufficientlysharp for transecting a captured tissue comprising a first thickness butmay not be sufficiently sharp for transecting a captured tissuecomprising a second thickness greater than the first thickness, forexample. In certain instances, a sharpness level of the cutting edge182, as defined by the force required for the cutting edge 182 totransect a captured tissue, may be adequate for transecting the capturedtissue if the captured tissue comprises a tissue thickness that is in aparticular range of tissue thicknesses, for example. In certaininstances, the memory 4317 (FIGS. 38, 39) can store one or morepredefined ranges of tissue thicknesses of tissue captured by the endeffector 300; and predefined threshold forces associated with thepredefined ranges of tissue thicknesses. In certain instances, eachpredefined threshold force may represent a minimum sharpness level ofthe cutting edge 182 that is suitable for transecting a captured tissuecomprising a tissue thickness (Tx) encompassed by the range of tissuethicknesses that is associated with the predefined threshold force. Incertain instances, when the force (Fx) required for the cutting edge 182to transect the captured tissue, comprising the tissue thickness (Tx),exceeds the predefined threshold force associated with the predefinedrange of tissue thicknesses that encompasses the tissue thickness (Tx),the cutting edge 182 may not be sufficiently sharp to transect thecaptured tissue, for example.

The method 4370 shown in FIG. 42 begins with clamping 4372 the tissue.Once the tissue to be transected is clamped, the thickness of the tissueis sensed 4374. After the tissue thickness is sensed 4374, firing of thesurgical instrument can be initiated 4376 by the user. Once the surgicalinstrument begins firing, the force (Fx) applied to the cutting edge 182(FIG. 20) is sensed 4378. The force (Fx) and the tissue thickness (Tx)is then compared 4380 to predetermined tissue thickness ranges and forceranges required to adequately transect the predetermined tissuethicknesses. For example, if the force (Fx) sensed is greater than apredetermined force range required to adequately transect tissue at thetissue thickness (Tx) that was sensed for the tissue clamped, a displaywill display 4386 an alert to the user that the cutting edge 182 isdulling. When the force (Fx) sensed is within the predetermined forcerange required to adequately transect tissue at the tissue thickness(Tx) that was sensed for the tissue clamped, the display may display4382 nothing. In both instances, the surgical instrument continues 4384firing to transect the tissue.

In various aspects, the present disclosure provides techniques fordetermining tissue compression and additional techniques to control theoperation of the instrument 10 (described in connection with FIGS. 1-29)in response to the tissue compression. In one example, the cartridgesmay be configured to define variable compression algorithm which drivesinstrument 10 to close differently based on intended tissue type andthickness. In another example, the instrument 10 learns from surgeon useand original tissue compression profile to adapt closure based on loadexperienced during firing. When the instrument 10 experiences tissuecompression loads that are dramatically different that those experiencedfor this cartridge type the instrument highlights this to the user.

Active adjustment of a motor control algorithm over time as theinstrument become acclimated to the hospital's usage can improve thelife expectancy of a rechargeable battery as well as adjust totissue/procedure requirements of minimizing tissue flow, thus improvingstaple formation in the tissue seal.

Accordingly, the present disclosure relates to surgical instruments and,in various circumstances, to surgical stapling and cutting instrumentsand staple cartridges therefor that are designed to staple and cuttissue. For example, in various aspects the present disclosure providesan endosurgical instrument configured to sense the cartridge type ortissue gap to enable the handle to adjust the closure and firingalgorithms to adjust for intended tissue properties. This adaptivealgorithm adjustment can “learn” from the user's operations allowing thedevice to react and benefit two different systems. The first benefitprovided by the disclosed adaptive algorithm includes tissue flow andstaple formation. As the device learns the users' basic habits and steptimings, the device can adjust the closure speed and firing speed toprovide a more consistent and reliable output. The second benefitprovided by the disclosed adaptive algorithm is related to the batterypack. As the device learns how many firings and what conditions theinstrument was used, the device can adjust motor current needs/speed ina predefined manner to prolong battery life. There is a substantiallysmall likelihood that a device used in a hospital that performspredominantly bariatric procedures would be operated in a manner similarto a device used in a hospital that performs mostly colorectal orthoracic procedures. Thus, when the device is used to performsubstantially similar procedure, over time, the device is configured tolearn and adjust its operational algorithm to maintain within the“ideal” discharge and tissue flow envelopes.

Safe and effective surgery requires due knowledge of, and respect for,the tissue involved. Clinicians are mindful that adjustments made duringsurgery may be beneficial. These adjustments include mechanisms todetect and promote desirable staple formation.

Endosurgical instruments can generate, monitor and process a substantialamount of data during their use in connection with a surgical procedure.Such data can be obtained from the surgical instrument itself, includingbattery usage. Additionally, data can be obtained from the properties ofthe tissue with which the surgical instrument interacts, includingproperties such as tissue compression. Further, data can be obtainedfrom the clinician's interaction with the surgical instrument itself.The repository of data so obtained can be processed and, where desired,the surgical instrument can be designed to adapt to circumstances so asto promote a safe and effective outcome to the current surgicalprocedure, as well as lay the foundation for more generalized productiveuse by multiple clinicians. Such adaptive adjustments—both during asurgical procedure, and wherein the instrument “learns” based on usagepatterns drawn from multiple surgical procedures—can provide numerousmechanisms to enhance the overall patient-care environment.

FIG. 43 illustrates one aspect of a process for adapting operations of asurgical instrument. As shown in FIG. 43, in various examples, anadaptive algorithm framework 5000 is provided. A staple cartridge can beidentified 5060. Control measures, such as algorithms, can be selected5062 based on the cartridge identified. These algorithms may include oneor more variable compression algorithms that drives instrument 10 (FIGS.1-4) to close in a different manner based on an expected tissue typeand/or thickness. Tissue properties can be identified 5064 as an aid toselection of control measures. The clinician can operate 5066 instrument10 to carry out a surgical procedure, including but not limited tostapling and/or incising tissue. Control measures can be modified 5068,with or without reference to data observed or generated during thecourse of a surgical procedure.

A surgical procedure can entail generating a significant amount of dataon parameters. By way of non-limiting example, these parameters caninclude those associated with surgical instrument 10 (FIGS. 1-4) itselfand its functionality, including but not limited to: speed of closure ofthe anvil 306 (FIG. 1) and staple cartridge 304 (FIG. 1), or speed ofclosure of anvil 306 and second jaw member 302 (FIG. 1); gap (e.g.,distance) between anvil 306 and staple cartridge 304, or anvil 306 andsecond jaw member 302; voltage; current; motor(s') speed; powermanagement, e.g., battery use; or sensor operation and accuracy.

Additional parameters that may be generated and observed in connectionwith a surgical procedure can also include those derived from the tissuebeing operated upon, including but not limited to: tissue compression;tissue thickness; tissue flow; tissue creep; tissue pressure; tissuestabilization; whether end effector 300 (FIG. 1) clamps a full orpartial bite of tissue, and whether such partial bite is proximal ordistal; speed of closure drive system 30 (FIG. 1); speed of firing drivesystem 80 (FIG. 4); staple performance; and/or determination if thetissue profile is consistent with healthy tissue or diseased tissue.

Further parameters that may be generated and observed in connection witha surgical procedure can also include those derived from the clinician,such as frequency of actuating closure trigger 32 (FIG. 1) by clinician;force applied on closure trigger 32 by clinician; frequency of actuatingfiring trigger 130 (FIG. 4) by clinician; force applied on firingtrigger 130 by clinician; and/or step timing by clinician.

Even more, parameters can include to what extent the instrument 10:experiences tissue compression loads different from those expected forthe cartridge type; experiences a wait period (such as for tissue creep)different from that expected; experiences a firing speed different fromthat expected; has undergone one or more sterilization cycles; and/orexperiences different or similar patterns of use based on the clinicalsetting. For example, there may be meaningful differences among use ofthe instrument in a setting directed primarily to bariatric, colorectal,or thoracic procedures respectively.

On top of these, parameters can include accuracy and appropriateness ofcontrol measures themselves, such as algorithms, used in connection withoperating the instrument. Feedback loops and/or logic paths can bedeveloped that include one or more of algorithms, data based oninstrument operation 5070, data based on the treatment site 5072, databased on clinician conduct 5074, and more. Added parameters can beconsidered and developed.

It will be apparent that there are numerous data resources that can bederived from a single surgical procedure. These data resources can beanalyzed in various manners including as a single data point, aplurality of data points, a range or ranges, as a range or ranges, orbased on added metrics such as rate of change of current, voltage,speed, or other parameter. Taking into account one, or many, of thesedata resources can enhance the safety and effectiveness of a singleprocedure.

In addition, these data resources can enhance the safety andeffectiveness of future procedures by the same clinician to the extentthat the surgical instrument can “learn” the basic habits and steptimings of the clinician. In addition, data can be aggregated frommultiple clinicians, further enabling the successful calibration of thesurgical instrument in the context of the surgical procedure. It can beappreciated that the hospital or health center in which the data iscompiled can develop a unique profile that can further enhance healthoutcomes. In addition, battery life can be prolonged, as it is learnedhow many firings and under what conditions the surgical instrument 10 isused. Thus, arrangements to adapt to numerous battery usage metrics arecontemplated in examples.

Instrument 10 (FIGS. 1-4) can determine whether, based on data obtained5070, 5072, 5074, a control measure is appropriate or not by variousmechanisms. One mechanism is by identifying a predetermined value orvalues. Such value or values can comprise an acceptable, or expected,parameter. If data obtained 5070, 5072, 5074 leads to a determinationthat an acceptable range has been exceeded, then a new controlmeasure(s) can be identified 5076 and control measures can be modified5078 including setting forth a new acceptable value. Exceeding a rangecan be considered to mean going above a range, below or range, orotherwise going beyond a range. The second control measure can be aminor adaptation of the first control measure, or it can be an entirelynew control measure. It will also be appreciated that the predeterminedacceptable range can be a single data point, multiple data points, afunction or other calculable equation, or any mechanism by which it canbe determined that a measurement, property or other metric that can beresolvable into a calculable value differs from an actual, expected orpredicted value. It is also understood that a control measure can becompared with another control measure, and the differentialeffectiveness of each determined, thus forming an input into anotherdetermination of whether and which control measures to adopt. Putanother way, success of control measures can represent an input.

In addition, expected values for parameters can be embedded in controlmeasures. In other words, an expected set of values for a tissueproperty can be embedded in a control measure that has been associatedwith instrument 10 (FIGS. 1-4). Thus, it will be evident that numerousexpected values for numerous parameters can be populated into numerouscontrol measures. These expected values can be referenced duringoperations of the instrument in order to determine control measurescarried out by instrument 10. Further, observed values can be detectedand analyzed by instrument 10 during operation. These observed valuescan be referenced and help determine the course of selection of currentand future control measures of the instrument 10 during the procedure,and also programmed into instrument 10 to set new or modified benchmarksto help determine an acceptable range or ranges of control measures.Further predictions can be made during operation of the instrument 10.The predictions can inform the processing and analysis of measurements,can lead to modifying control measures, and generally adapting tooperational circumstances.

Thus, data can be obtained from multiple sources. One source is databased on operation of the instrument (e.g., closure speed) 5070. Anothersource of data can be that derived from the treatment site 5072 (e.g.,tissue thickness). A further source of data can be that based onclinician conduct 5074 (e.g., firing habits). Once this data 5070, 5072,5074 is obtained, the appropriateness of control measures can beassessed 5076. For example, a certain tissue type may have beenexpected, and this tissue type was experienced during the procedure.However, it may be that the exudation resulting from clamping washeavier than anticipated. Also, it may be that the clinician has a habitof applying more pressure than may be desirable on the firing trigger130 (FIG. 1). In short, there may be many data sources that can beconsulted to analyze, improve on and potentially optimize efficacy ofcurrent and future uses of the instrument. As a result, control measurescan be modified 5078 during and/or after a procedure for maximumsuccess.

In one aspect, surgical instrument 10 (FIGS. 1-4) can comprise aplurality of modules, based on control mechanisms configurable from acontroller and/or other processor, memory, and other systems therein fortransmission, communication and processing of data. One of multiplepossible modules can be based on a feedback system, as generalizedand/or customized for a specific purpose or system. In addition, it willbe apparent that there will be a processor 4315 (FIGS. 38, 39) andmemory 4317 (FIGS. 38, 39) in operative communication with the surgicalinstrument 10 that can permit the functionality discussed herein.

FIG. 44 illustrates one aspect of a process for adapting operations of asurgical instrument. As depicted in FIG. 44, a module can be attached5160 or otherwise loaded to instrument 10 (FIGS. 1-4). The module cancontain a program that is selected or uploaded 5162. Controls can beactivated 5164 such that they can be ready to operate instrument 10.During or after usage of instrument 10, a program, including controlmeasures, can be adapted 5166. For example, this can include adjustingthe data rate within the instrument 10 or with respect to remoteoperation of the instrument 10. This can include adjusting speed, suchas speed by which anvil 306 (FIG. 1) and cartridge 304 (FIG. 1) engagein a closure motion. This can also include a pulse from an emitter andsensor or to apply a pulse of electrical current to tissue, and thetiming of such pulse. This can include adjusting a program to adapt toacceleration, such as acceleration of the instrument 10 if dropped, ortransition from a sleep mode. A program can be adapted to handle anactual and/or expected load based on clamping force.

Instrument 10 (FIGS. 1-4) can be employed to complete an action 5168,for example to carry out a stapling procedure. Data can be recorded 5170in appropriate memory locations of instrument 10. Sensor behavior 5172can be assessed, such as to what extent a sensor accurately measuredand/or measures a parameter. Anticipated data can be assessed 5174,including but not limited to tissue properties, wait period and firingspeed. Foregoing mechanisms disclosed herein can provide an input toadapt a program 5166 further. In addition, a tissue identification 5178can be performed, based on historical, actual or expected tissueproperties, and this can provide an input to adapt a program 5166further. In addition, tissue identification 5178 properties can beupdated. Moreover, measured sensor input 5176 during a procedure can beused as an additional input to adapt a program 5166 further; such sensormeasurements can include those of the gap between anvil 306 andcartridge 304, obtaining a derivative measurement including a derivativeof a function, current, or torque.

FIG. 45 illustrates one aspect of a mechanism for adapting operations ofa surgical instrument in the context of closure motion and tissuepressure. In various aspects, closure motion 5216 can be adjusted basedon a parameter. An example parameter can be average tissue pressure5218. FIG. 45 is a diagram that illustrates three phases of carrying outa procedure with instrument 10 (FIGS. 1-4). Time (t) is shown along abottom horizontal axis 5220, a bottom vertical axis represents averagetissue pressure 5218 applied to tissue clamped between the jaw membersof the end effector. A top vertical axis represents closure motion 5216of the anvil 306 (FIG. 1) towards the cartridge 304 (FIG. 1) to engagetissue therebetween in a closure motion. A top horizontal axisrepresents closing 5210 of the anvil 306 (FIG. 1) of end effector toengage a cartridge 304 (FIG. 1) or second jaw member 302 (FIG. 1),tissue creep 5212 wherein material is allowed to exudate from the tissuesection held within end effector 300 (FIG. 1), and firing 5214, whichcan comprise deploying a staple cartridge 304, applying electrosurgicalenergy, incising tissue, or other suitable surgical event. An anvil 306can begin to close on a second jaw member 302, which is configured toreceive a staple cartridge 304 therein. As anvil 306 closes towardcartridge 304 during a clamping operation, tissue pressure is determinedby one or more mechanisms, such as by reference to one or more sensors.A plurality of sensors may comprise one or more identical sensors and/ordifferent sensors. The plurality of sensors may comprise, for example,magnetic sensors, such as a magnetic field sensor, strain gauges,pressure sensors, inductive sensors, such as an eddy current sensor,resistive sensors, capacitive sensors, optical sensors, and/or any othersuitable sensors or combination thereof.

During the closing phase 5210, the closure motion 5216 versus time ofthe jaw members is compared with average tissue pressure 5218 versustime. A first average tissue pressure versus time curve, represented bya dashed line includes three segments, includes a first segment 5286during the closing phase 5210 of the anvil 306 (FIG. 1) towards thecartridge 304 (FIG. 1) to apply pressure against the tissue graspedtherebetween. A second segment 5260 represents the tissue pressureduring the tissue creep 5212 phase where the anvil 304 has stoppedmoving and the tissue is given an opportunity to creep. A third segmentrepresents the tissue pressure during the firing phase during which thestaples are deployed to seal the tissue ahead of advancement of thecutting member to cut the tissue.

A second average tissue pressure versus time curve, represented by adashed-dot line, represents a typical curve observed when the anvil 306(FIG. 1) is closing too fast 5254. This is represented by the firstsegment 5152 where the slope P2 of the average tissue pressure 5218versus time is too steep during the closure motion curve segment 5230during the acceleration of the closure motion and curve segment 5234when the closure motion 5216 remains steady until a threshold 5236average tissue slope 5218 is detected at which time the closure motiondrops to a lower constant value shown by curve segment 5238 at whichtime the slope of the average tissue pressure 5216 curve segment 5256decreases to reflect the slower closure motion 5216.

A third “ideal” tissue pressure versus time curve 5258 having an idealslope is represented by a solid line curve segment 5250.

The tissue creep 5212 phase is entered after the tissue is grasped andthe average tissue pressure reaches a predetermined threshold and theclosure motion 5216 stops such that the jaw members, e.g., anvil 306(FIG. 1) and cartridge 304 (FIG. 1), hold the tissue therebetween for apredetermined time before initiating the firing 5214 phase in which thestaples and knife are deployed. During the tissue creep 5212 phase theaverage tissue pressure drops over the time period between closing 5210and firing 5214 phases. The dashed-dot curve (adjusted closing too fastcurve) and solid curve (ideal closing speed) segments 5262 overlap.

At a predetermined time 5248, the firing 5214 phase initiates. A typicalfiring 5214 cycle is represented by the dashed line average tissuepressure curve segment 5266. An ideal firing 5214 cycle is representedby the solid line average tissue pressure curve segment 5264 where theslope P1 increases 5270, reaches a peak 5272, and then gently decreases5276. When the firing 5214 phase moves too rapidly as indicated by curvesegment 5240, the slope P2 of the dashed-dot line average tissuepressure curve 5266 rises too steeply. When a predetermined slopethreshold is detected, the firing speed is maintained constant asrepresented by firing curve speed segment 5242 and the slope 5270 of thedashed-dot line average tissue pressure curve 5266 decreases. After apredetermined time, the firing speed drops to a lower speed asrepresented by the firing speed curve segment 5246. After allowing forsystem response times, the dashed-dot line coincides with the solid lineduring the lower firing speed 5246.

Closure motion 5216, such as speed of closure, or another measured raterelated to closure, can be determined. As the clamping operationprogresses, and a parameter increases 5230, average tissue pressure isbeing measured. The parameter in question can be but is not limited tospeed. Average tissue pressure can be plotted graphically. A curve 5252described by such graph can be plotted. At a certain point closuremotion 5216 can be steady 5232. However, a tissue pressure reading cansuggest that the closure motion rate is too fast 5254 as indicated by,for example, the slope of curve 5252. It can also be the case that theclosure motion rate was too fast, or is predicted to be too fast in thefuture. This can occur during a period where closure rate is steady5232, or during a period where closure rate drops 5234 such as wherethick, fluid-filled or unexpectedly dense tissue is encountered, amongother reasons. Fluid in tissue could cause thickness to increasetemporarily, causing undesirable staple deployment. To the extent thatit is detected that the slope of average tissue pressure curve 5218 isgrowing too steep, adjustments can be made. It will also be appreciatedthat, independent of or in conjunction with slope, a secondarycalculation can be made based on the observed parameters suggesting thatthe closure rate is too fast. An adjustment can be made, such as bydecreasing the rate of change of closure motion 5216. For example, anideal closing speed can be referenced based on stored control measuresor dynamically obtained control measures, or both. An average tissuepressure curve reflecting such ideal closing speed 5258 can bereferenced.

Accordingly, curve 5258 can influence closure motion 5216 such that therate of closure is decreased 5238 or otherwise modified to adapt tocircumstances encountered during a surgical procedure. It will beunderstood that an ideal closing speed can represent an optimal closingspeed, or one within a range of adequate closing speeds.

Compression of clamped tissue can precede the firing 5214 phase. It maybe desired that compression reach a certain average tissue pressure,and/or that the tissue is considered stabilized such that firing 5214can be warranted. A measured tissue pressure can be reached at a point,for example, representing the intersection of curve 5252 and 5250. Uponreaching this point, the tissue can be allowed to stabilize and theexudate seep from the tissue. Tissue, in part because it is composed ofsolid and liquid material, tends to elongate when compressed; one way toaccount for this property is “tissue creep”. When tissue is compressed,a certain amount of tissue creep 5212 can occur. Affording thecompressed tissue an adequate amount of time under certain circumstancesto accomplish tissue creep can therefore produce benefits. One benefitcan be adequate staple formation. This can contribute to a consistentstaple line. Accordingly, a certain time can be given to enable tissuecreep 5212 prior to firing 5214.

Upon reaching a desirable point, firing 5214 can be commenced. Firing5214 can comprise one or more actions or events, including deployment ofan I-beam and/or other firing member towards and/or within end effector300 (FIG. 1). An I-beam can comprise a cutting member deployabletherein. The cutting member can comprise, for example, an I-Beamconfigured for simultaneously cutting of a tissue section locatedbetween an anvil 306 (FIG. 1) and a staple cartridge 304 (FIG. 1) anddeploying staples from the staple cartridge 304.

During firing 5214, average tissue pressure can ascend along curve 5266,comparable with the rate of closure motion 5216. A slope can becalculated for average tissue pressure during firing 5214. The slope canbe evaluated to be steeper than desired, perhaps due to an increasingrate of average tissue pressure change in combination with a stablefiring rate 5242. If this condition or another condition provided for isdetected, instrument 10 (FIGS. 1-4) can have the capability to adapt.Measures can be implemented to modify the firing curve 5268 such that apeak can be reached that would be similar to or identical to thatobtainable from a more desirable tissue pressure curve 5274.

Accordingly, similar to adaptive mechanisms employed in connection withclosing 5210, adaptive measures can be employed in connection withfiring 5214.

Tissue-pressure curve 5286 can be referenced which can track a desiredtissue-creep rate after reference to an ideal closing speed.Tissue-pressure curve 5286 can be programmed to operate in conjunctionwith, or be extrapolated from, the closing phase 5210 or firing phase5214. Additionally, a given tissue type can be referenced that wouldgive certain characteristics when surgical operations are carried outthereon, such characteristics embodying curve 5286. It will beappreciated that various purposes can be fulfilled by referencingtissue-pressure curve 5286, or another tissue-pressure curve, that mightbe considered an “ideal”, desired, or otherwise “reference curve”. Sucha reference curve can assist in improving closing 5210, tissue creep5212, and/or firing 5214. Such a reference curve or curves can be storedin instrument 10 (FIGS. 1-4) or be developed dynamically, or both, andcan account for varying thickness of a tissue portion, and many otherfactors.

In accordance with aspects, FIG. 46 illustrates adaptive mechanisms thatcan influence actual behavior of instrument 10 (FIGS. 1-4) in theprocess of carrying out a surgical procedure. Speed 5310 can beenumerated on the vertical (y) axis and time 5311 (t) is representedalong the horizontal axis. Speed 5310 can represent speed of the motor,speed of closure of end effector 300 (FIG. 1), speed of firing rate, oranother speed. As speed increases 5312, sensors can obtain measurementsof various parameters. Based on control measures derived from storedalgorithms, or dynamically generated algorithms, or both, one or moremodifications can be made. One modification can be a tissue modification5320 that will influence operation of instrument 10 such that speed isupwardly or downwardly adjusted in order to obtain a more desirable setof conditions. An additional modification can be a sensor modification5330. Sensor modification 5330 can influence the characteristics orvalues of data transmitted to microcontroller 1500 (FIG. 19) andoperatively associated memory units. Microcontroller 1500 can monitorand obtain data from sensors associated with for example end effector300. Sensor modification can also influence parameter readings at one ormore added sensor(s). For example, a primary sensor such as a magneticfield sensor located for example at a distal portion of anvil 306(FIG. 1) can indicate a certain thickness of a bite of tissue; however,reference to a secondary sensor such as a strain gauge can be factoredin such that the measured Hall effect voltage can be adjusted. As aresult, inputs such as tissue modification 5320 and sensor modification5330 can influence an actual speed 5340 that is adjusted to take intoaccount one or both.

Additionally, in accordance with aspects, FIG. 47 illustrates adaptivemechanisms that can influence actual behavior of a firing rate 5410 inthe process of carrying out a surgical procedure. Firing rate 5410 canbe enumerated on the vertical (y) axis and time 5412 (t) is representedalong the horizontal (x) axis. Firing rate 5410 can represent a rate atwhich a firing member 220 (FIGS. 1 and 7) is longitudinally deployed, arate at which tissue is incised, and/or a rate at which staples aredeployed. In various examples, a firing rate 5410 value can ascend, uponactuation of a firing mechanism. Based on control measures derived frompredetermined algorithms, or dynamically generated algorithms, or both,one or more modifications can be made to an original program in thememory that can define the firing rate (here, a steady firing rate5420). One modification can be a tissue modification 5430 that caninfluence operation of instrument such that speed is upwardly ordownwardly adjusted in order to obtain a more desirable set ofconditions. An additional modification can be a sensor modification5440. Sensor modification 5440 can influence the characteristics orvalues of data transmitted to microcontroller 1500 from sensorsassociated with for example end effector 300 (FIG. 1). Sensormodification 5440 can also influence parameter readings at one or moreadded sensor(s). For example, a primary sensor such as a magnetic fieldsensor on end effector 300 can indicate a certain thickness of a bite oftissue; however, reference to a secondary sensor such as a strain gaugecan be factored in such that the measured Hall effect voltage can beadjusted. As a result, inputs such as tissue modification 5430 andsensor modification 5440 can influence an actual speed 5450 that isadjusted to take into account one or both.

Inputs can be given their actual weight, i.e., without selectiveweighting. However, in various aspects one or more inputs may not beweighted equally. Certain inputs may be given more weight than otherinputs.

Adequate staple formation is a key consideration. Factors that influencestaple formation include finding desirable operational envelopes basedon tissue compression. FIGS. 48 and 49 illustrate example scenarioswhere a parameter such as differential tissue compression, as measuredby impedance sensors, can result in adaptive firing procedures. FIG. 48illustrates clamping 5510 operations where tissue compression 5514 isshown along the vertical (y) axis and staple cartridge size 5532 (mm) isshown along the horizontal (x) axis. Measurements from an end effector300 (FIG. 1) can embrace a tissue portion of length up to 60 mm in thisexample, though it can be of a greater length in other examples. Tissuecompression within the clamping end effector 300 can be measured byimpedance sensors positioned, for example, every 6 mm, such as from 6mm-60 mm. An impedance measurement can be taken at each sensor. During asurgical procedure, tissue can be compressed within end effector 300.Impedance measurements can be taken at times t1 5516 and t2 5518. Attime t1 5516, a curve 5522 can be described toward 5520 by monitoringimpedance measurements from one more of the impedance sensors (includingimpedance sensors 5526, 5528 and 5530). It will be appreciated thatthere may be ten impedance sensors as shown in the example, but theremay be more or fewer. At a second time, t2 5518, a curve 5524 can bedescribed toward 5523 by monitoring the same impedance measurements fromone more of the impedance sensors (including impedance sensors 5526,5528 and 5530). Impedance can be measured based on values from one ormore of the impedance sensors, along a curve toward 5524. Comparing theimpedance values for a given sensor from t1 and t2 can reveal adifferential based on staple line length 5512. There may be multiplereasons. One reason can be that the clamped tissue exhibits differentcompression properties at different locations along staple line length5512. An additional reason can be that there is a different tissuethickness; in other words, the tissue may exhibit pre-clamping thicknessof a profile seen in FIG. 51. Further, tissue creep may have played arole. It is possible that all these reasons contribute to the observedproperties, or there are other reasons. In any event, differentialtissue compression over time can be observed.

FIG. 49 can illustrate a firing operation 5610, including but notlimited to a firing operation based on FIG. 48. In FIG. 49, tissuecompression 5612 is shown along a vertical (y) axis and staple cartridgesize 5622 (mm) is shown along the horizontal (x) axis. As the I-beamtraverses the tissue, tissue compression 5612 measurements are taken bymonitoring impedance measurements from one more of the impedance sensors(including impedance sensors 5618, 5620 and 5624). During firing, tissuecompression 5612 can rise to a threshold 5630 and then peak at time t35670 relative to I-beam location 5614. Subsequently, tissue compressionfalls between t3 5670 and t4 5672 (e.g., 1 second 5660) relative toI-beam location 5616. This operation can describe a rising curve 5640and a falling curve 5642. It also may be observed that under certaincircumstances a rising curve 5640 can exhibit a convex complexion, and afalling curve a concave complexion 5642. It may be predicted that anI-beam may take more time to traverse tissue with certaincharacteristics, e.g., thicker tissue, diseased tissue, etc.Accordingly, a different tissue compression profile may be prescribedsuch that tissue compression measurements observe a second curve 5650,5652. In addition, second curve 5650, 5652 may result where there is adifferential thickness of the pre-clamped tissue, such as that seen inFIG. 51. Portion 5810 is thinner than portion 5812. Traversing thickertissue can act to slow the relative speed of the I-Beam, leading todifferent tissue compression measurements over time, and accordinglyvariable tissue profiles.

Accordingly, a differential in tissue compression measurements betweent1 and t2 can lead to an adaptive response whereby control measuresadjust a curve of tissue compression during a firing phase 5610. It willbe appreciated, then, that the curve peaking at t4 can represent anadaptive curve based on tissue properties that can lead to improvedresults from the surgical procedure, battery usage, and other operationswhere an adaptive response can be used.

The shape of the curve can have significance. For example, a convexcurve can reflect a rising tissue compression profile during a firingphase 5610. A concave curve can reflect a falling tissue compressionprofile during a firing phase 5610. A peak tissue compressionmeasurement 5670, 5672 can fall between respective concave and convexcurves. (For purposes of this disclosure, a perspective based on whichconcavity or convexity is found is based on viewing from a higher valueon the y-axis than the peak of the curve.)

In conjunction with FIGS. 48 and 49, or as independent examples, controlmeasures can wholly or partially adjust firing in order to prevent aparameter from rising above a certain limit. FIG. 50 shows an examplescenario. A first curve 5730, 5732 can be a predicted firing profilestored by instrument 10 (FIGS. 1-4) for a given type of tissue. It willbe seen that the vertical (y) axis parameter, such as tissuecompression, over time (t) along the horizontal (x) axis 5172 can riseas in curve 5730, then fall as in curve 5732. However, it is possiblethat the values associated with the predicted firing profile diverge,during operation, from values actually observed during the surgicalprocedure. As a result, instrument 10 can take measures to adapt. Forexample, the observed measurements can fall along curve 5720, with aslower rate of rise but projected higher peak. Thus, the y-axisparameter can continue to rise. Under certain circumstances, it can bepredicted that the curve for the y-axis parameter could breachpredetermined, or dynamically determined, limit 5710 prior to reachingits peak. This prediction can be made based on a slope 5722 of thecurve, in combination or not with input from the x-axis 5172 parameter(e.g., time). If it is determined that the peak is predicted to be abovethe limit 5726, or other portions of curve 5724 will breach the limit5710, instrument 10 could adapt firing in order to provide for a slowerfiring rate. Doing so can result in the y-axis measurement falling alongan adaptive curve 5728 based on slower firing. The adaptive curve canrise above the limit, or be constrained from doing by adaptingoperations accordingly.

FIG. 51 illustrates a portion of tissue prior to clamping. It can beseen that one end of the tissue 5810 is thinner than the other end 5812.In such circumstances, there can be differential forces and timingsexerted by end effector 300 (FIG. 1) on the tissue, and by the tissue onend effector 300. The thickness disparity can be taken into account byinstrument 10 (FIGS. 1-4) in adapting to such thickness. It may be thecase that this tissue portion is similar to the one considered inconnection with FIGS. 48-49. It also may be the case that another tissueportion is illustrated in connection with FIGS. 48-49, to show moregeneral applicability. It may further be the case that FIG. 50 is agraphical representation of adaptive operations performed in connectionwith a tissue portion like that in FIG. 51; again, it also may be thecase that FIG. 50 can show more generally adaptive operations inresponse to detecting measurement of certain parameters during thecourse of a surgical procedure and adjusting accordingly.

In various aspects, the present disclosure provides an instrument 10(described in connection with FIGS. 1-29) configured to sense tissuecompression when tissue is clamped between the jaw members of the endeffector, such as, for example, between the anvil and the staplecartridge. In one example, the instrument 10 (FIGS. 1-4) can beconfigured to sense tissue contact in one of the jaw members such as theanvil and/or the staple cartridge. In another example, the instrument 10can be configured to sense the pressure applied to the tissue by the jawmembers. In yet another example, the instrument 10 can be configured tomeasure the electrical impedance (resistance) through the tissue betweenthe jaw members. This may be achieved by embedding micro electrodes inat least one of the jaw members to drive a low amplitude, low energy, RFsignal through the tissue to enable a nontherapeutic measurement oftissue impedance. The energy level is kept low enough to avoidtherapeutic tissue effects such as coagulation, sealing, welding, orcautery. Further, the instrument 10 can include devices to produce twodistinct measures from a single set of energized and return paths. Inone example, multiple frequency signals can be overlaid to measureimpedance in different places simultaneously. This can include a singleactive electrode with the channel and the anvil grounded throughisolated paths with filters for different frequency RF signals.Otherwise, two isolated return paths with independent filters, which arepart of the handle electronics system can be used. In another example,the sequential impedance measurements would be multiplexed at variableRF frequencies.

RF technology has been used in endocutters for some time. The challengein employing the technology is in the delivery of high density RF energyand shorting between the jaw members of the end effector. Despite theshortcomings of using RF energy therapeutically, RF technology can beeffectively employed sub-therapeutically to sense tissue compressionrather than actually coagulating, sealing, or cauterizing tissue. In thesub-therapeutic sense, the endosurgical device can employ RF energy tosense internal tissue parameters and adjust the deployment of staplesrather and being employed as an adjunct to the stapling operation toassist in sealing the tissue prior to cutting the tissue with a knife.

RF technology used in endosurgical medical devices, and for example, inRF endocutters, may introduce the challenges of handling high densitiesof energy and dealing with shorting. However, RF technology may be lesschallenging if used merely to sense tissue compression rather than, forexample, cauterizing tissue. RF technology may be used as a way formedical devices, such as endocutters, to sense internal tissueparameters such as compression, and adjust stapling deployment inresponse. RF electrode and cautery devices may utilize the sameelectrodes for sensing tissue impedance as they do to melt tissue. Thesesame electrodes may be implemented with significantly less electricaland power requirements as a tissue compression sensor system.

RF electrodes and cautery devices can utilize the same electrodes forsensing tissue impedance as they do to weld the tissue by applyingenergy thereto. Nevertheless, in the an endocutter instrument context,the RF electrodes can be employed to as a tissue compression sensorsystem with significantly less electronics and power needs relative to afully equipped electrosurgical device. A single energized electrode onthe cartridge, for example, or perhaps an isolated knife, can be used tomake multiple tissue compression measurements simultaneously. Ifmultiple RF signals are overlaid or multiplexed they can be transmitteddown the single power conductor and then allowed to return on either thechannel frame or the anvil of the device. If a filter is provided in theanvil and channel contacts before they join the common return path, thetissue impedance for both paths can be differentiated. This wouldprovide a measure of through tissue versus lateral tissue compression.This filtered approach may be implemented proximal and distal as opposedto vertical and lateral depending on the placement of the filters andthe location of the metallic electrically conductive return paths. Thesmaller frequency generator and signal processor may be implemented in asmall package form factor on an existing circuit board or a sub circuitboard without the need for extensive extra cost associated with an RFsealing/cauterization system.

Referring to FIG. 52, an endocutter 6000 may include a handle component6002, a shaft component 6004, and an end-effector component 6006. Theendocutter 6000 is similarly constructed and equipped as themotor-driven surgical cutting and fastening instrument 10 described inconnection with FIGS. 1-29. Accordingly, for conciseness and clarity thedetails of operation and construction will not be repeated here. Theend-effector 6006 may be used to compress, cut, or staple tissue.Referring now to FIG. 53A, an end-effector 6030 may be positioned by aphysician to surround tissue 6032 prior to compression, cutting, orstapling. As shown in FIG. 53A, no compression may be applied to thetissue while preparing to use the end-effector. Referring now to FIG.53B, by engaging the handle (e.g., handle 6002) of the endocutter, thephysician may use the end-effector 6030 to compress the tissue 6032. Inone aspect, the tissue 6032 may be compressed to its maximum threshold,as shown in FIG. 53B.

Referring to FIG. 54A, various forces may be applied to the tissue 6032by the end-effector 6030. For example, vertical forces F1 and F2 may beapplied by the anvil 6034 and the channel frame 6036 of the end-effector6030 as tissue 6032 is compressed between the two. Referring now to FIG.54B, various diagonal and/or lateral forces also may be applied to thetissue 6032 when compressed by the end-effector 6030. For example, forceF3 may be applied. For the purposes of operating a medical device suchas endocutter 6000, it may be desirable to sense or calculate thevarious forms of compression being applied to the tissue by theend-effector. For example, knowledge of vertical or lateral compressionmay allow the end-effector to more precisely or accurately apply astaple operation or may inform the operator of the endocutter such thatthe endocutter can be used more properly or safely.

The compression through tissue 6032 may be determined from an impedanceof tissue 6032. At various levels of compression, the impedance Z oftissue 6032 may increase or decrease. By applying a voltage V and acurrent I to the tissue 6032, the impedance Z of the tissue 6032 may bedetermined at various levels of compression. For example, impedance Zmay be calculated by dividing the applied voltage V by the current I.

Referring now to FIG. 55, in one aspect, an RF electrode 6038 may bepositioned on the end-effector 6030 (e.g., on a staple cartridge, knife,or channel frame of the end-effector 6030). Further, an electricalcontact 6040 may be positioned on the anvil 6034 of the end-effector6030. In one aspect, the electrical contact may be positioned on thechannel frame of the end-effector. As the tissue 6032 is compressedbetween the anvil 6034 and, for example, the channel frame 6036 of theend-effector 6030, an impedance Z of the tissue 6032 changes. Thevertical tissue compression 6042 caused by the end-effector 6030 may bemeasured as a function of the impedance Z of the tissue 6032.

Referring now to FIG. 56, in one aspect, an electrical contact 6044 maybe positioned on an opposite end of the anvil 6034 of the end-effector6030 as the RF electrode 6038 is positioned. As the tissue 6032 iscompressed between the anvil 6034 and, for example, the channel frame6036 of the end-effector 6030, an impedance Z of the tissue 6032changes. The lateral tissue compression 6046 caused by the end-effector6030 may be measured as a function of the impedance Z of the tissue6032.

Referring now to FIG. 57, in one aspect, electrical contact 6050 may bepositioned on the anvil 6034 and electrical contact 6052 may bepositioned on an opposite end of the end-effector 6030 at channel frame6036. RF electrode 6048 may be positioned laterally to the central tothe end-effector 6030. As the tissue 6032 is compressed between theanvil 6034 and, for example, the channel frame 6036 of the end-effector6030, an impedance Z of the tissue 6032 changes. The lateral compressionor angular compressions 6054 and 6056 on either side of the RF electrode6048 may be caused by the end-effector 6030 and may be measured as afunction of different impedances Z of the tissue 6032, based on therelative positioning of the RF electrode 6048 and electrical contacts6050 and 6052.

In accordance with one or more of the techniques and features describedin the present disclosure, and as discussed above, an RF electrode maybe used as an RF sensor. Referring now to FIG. 58, in one aspect, an RFsensor 6062 may be positioned on a staple cartridge 6060 inserted into achannel frame 6066 an end-effector. The RF electrode may run from apower line 6064 which may be powered by a power source in a handle(e.g., handle 6002) of an endocutter.

Referring now to FIG. 59, in one aspect, RF electrodes 6074 and 6076 maybe positioned on a staple cartridge 6072 inserted into a channel frame6078 of end-effector 6070. As shown, RF electrode 6074 may be placed ina proximal position of the end-effector relative to an endocutterhandle. Further, RF electrode 6076 may be placed in a distal position ofthe end-effector relative to the endocutter handle. RF electrodes 6074and 6076 may be utilized to measure vertical, lateral, proximal, ordistal compression at different points in a tissue based on the positionof one or more electrical contacts on the end-effector.

Referring now to FIG. 60, in one aspect, RF electrodes 6084-6116 may bepositioned on staple cartridge 6082 inserted into the channel frame 6080(or other component of an end-effector) based on various points forwhich compression information is desired. Referring now to FIG. 61, inone aspect, RF electrodes 6122-6140 may be positioned on staplecartridge 6120 at discrete points for which compression information isdesired. Referring now to FIG. 62, RF electrodes 6152-6172 may bepositioned at different points in multiple zones of a staple cartridgebased on how accurate or precise the compression measurements should be.For example, RF electrodes 6152-6156 may be positioned in zone 6158 ofstaple cartridge 6150 depending on how accurate or precise thecompression measurements in zone 6158 should be. Further, RF electrodes6160-6164 may be positioned in zone 6166 of staple cartridge 6150depending on how accurate or precise the compression measurements inzone 6166 should be. Additionally, RF electrodes 6168-6172 may bepositioned in zone 6174 of staple cartridge 6150 depending on howaccurate or precise the compression measurements in zone 6174 should be.

The RF electrodes discussed herein may be wired through a staplecartridge inserted in the channel frame. Referring now to FIG. 63, inone aspect, an RF electrode may have a stamped “mushroom head” 6180 ofabout 1.0 mm in diameter. While the RF electrode may have the stamped“mushroom head” of about 1.0 mm in diameter, this is intended to be anon-limiting example and the RF electrode may be differently shaped andsized depending on each particular application or design. The RFelectrode may be connected to, fastened to, or may form, a conductivewire 6182. The conductive wire 182 may be about 0.5 mm in diameter, ormay have a larger or smaller diameter based on a particular applicationor design. Further, the conductive wire may have an insulative coating6184. In one example, the RF electrode may protrude through a staplecartridge, channel frame, knife, or other component of an end-effector.

Referring now to FIG. 64, the RF electrodes may be wired through asingle wall or through multiple walls of a staple cartridge or channelframe of an end-effector. For example, RF electrodes 6190-6194 may bewired through wall 6196 of the staple cartridge or channel frame of anend-effector. One or more of wires 6198 may be connected to, fastenedto, or be part of, RF electrodes 6190-6194 and may run through wall 6196from a power source in, e.g., a handle of an endocutter.

Referring now to FIG. 65, the power source may be in communication withthe RF electrodes or may provide power to the RF electrodes through awire or cable. The wire or cable may join each individual wire and leadto the power source. For example, RF electrodes 6204-6212 may receivepower from a power source through wire or cable 6202, which may runthrough staple cartridge 6200 or a channel frame of an end-effector. Inone example, each of RF electrodes 6204-6212 may have its own wire thatruns to or through wire or cable 6202. The staple cartridge 6200 orchannel frame also may include a controller 6214, such as the controller2006 shown in connection with FIGS. 21A, 21B, or other controllers 2606or 3017 shown in connection with FIGS. 27-29, for example. It will beappreciated that the controller 6214 should be suitably sized to fit inthe staple cartridge 6200 or channel frame form factor. Also, thecontroller

In various aspects, the tissue compression sensor system describedherein for use with medical devices may include a frequency generator.The frequency generator may be located on a circuit board of the medicaldevice, such as an endocutter. For example the frequency generator maybe located on a circuit board in a shaft or handle of the endocutter.Referring now to FIG. 66, an example circuit diagram 6220 in accordancewith one example of the present disclosure is shown. As shown, frequencygenerator 6222 may receive power or current from a power source 6221 andmay supply one or more RF signals to one or more RF electrodes 6224. Asdiscussed above, the one or more RF electrodes may be positioned atvarious locations or components on an end-effector or endocutter, suchas a staple cartridge or channel frame. One or more electrical contacts,such as electrical contacts 6226 or 6228 may be positioned on a channelframe or an anvil of an end-effector. Further, one or more filters, suchas filters 6230 or 6232 may be communicatively coupled to the electricalcontacts 6226 or 6228 as shown in FIG. 66. The filters 6230 and 6232 mayfilter one or more RF signals supplied by the frequency generator 6222before joining a single return path 6234. A voltage V and a current Iassociated with the one or more RF signals may be used to calculate animpedance Z associated with a tissue that may be compressed and/orcommunicatively coupled between the one or more RF electrodes 6224 andthe electrical contacts 6226 or 6228.

Referring now to FIG. 67, various components of the tissue compressionsensor system described herein may be located in a handle 6236 of anendocutter. For example, as shown in circuit diagram 6220 a, frequencygenerator 6222 may be located in the handle 6236 and receives power frompower source 6221. Also, current I1 and current I2 may be measured on areturn path corresponding to electrical contacts 6228 and 6226. Using avoltage V applied between the supply and return paths, impedances Z1 andZ2 may be calculated. Z1 may correspond to an impedance of a tissuecompressed and/or communicatively coupled between one or more of RFelectrodes 6224 and electrical contact 6228. Further, Z2 may correspondto an impedance of a tissue compressed and/or communicatively coupledbetween one or more of RF electrodes 6224 and electrical contact 6226.Applying the formulas Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2corresponding to different compression levels of a tissue compressed byan end-effector may be calculated.

Referring now to FIG. 68, one or more aspects of the present disclosureare described in circuit diagram 6250. In an implementation, a powersource at a handle 6252 of an endocutter may provide power to afrequency generator 6254. The frequency generator 6254 may generate oneor more RF signals. The one or more RF signals may be multiplexed oroverlaid at a multiplexer 6256, which may be in a shaft 6258 of theendocutter. In this way, two or more RF signals may be overlaid (or,e.g., nested or modulated together) and transmitted to the end-effector.The one or more RF signals may energize one or more RF electrodes 6260at an end-effector 6262 (e.g., positioned in a staple cartridge) of theendocutter. A tissue (not shown) may be compressed and/orcommunicatively coupled between the one or more of RF electrodes 6260and one or more electrical contacts. For example, the tissue may becompressed and/or communicatively coupled between the one or more RFelectrodes 6260 and the electrical contact 6264 positioned in a channelframe of the end-effector 6262 or the electrical contact 6266 positionedin an anvil of the end-effector 6262. A filter 6268 may becommunicatively coupled to the electrical contact 6264 and a filter 6270may be communicatively coupled to the electrical contact 6266.

A voltage V and a current I associated with the one or more RF signalsmay be used to calculate an impedance Z associated with a tissue thatmay be compressed between the staple cartridge (and communicativelycoupled to one or more RF electrodes 6260) and the channel frame oranvil (and communicatively coupled to one or more of electrical contacts6264 or 6266).

In one aspect, various components of the tissue compression sensorsystem described herein may be located in a shaft 6258 of theendocutter. For example, as shown in circuit diagram 6250 (and inaddition to the frequency generator 6254), an impedance calculator 6272,a controller 6274, a non-volatile memory 6276, and a communicationchannel 6278 may be located in the shaft 6258. In one example, thefrequency generator 6254, impedance calculator 6272, controller 6274,non-volatile memory 6276, and communication channel 6278 may bepositioned on a circuit board in the shaft 6258.

The two or more RF signals may be returned on a common path via theelectrical contacts. Further, the two or more RF signals may be filteredprior to the joining of the RF signals on the common path todifferentiate separate tissue impedances represented by the two or moreRF signals. Current I1 and current I2 may be measured on a return pathcorresponding to electrical contacts 6264 and 6266. Using a voltage Vapplied between the supply and return paths, impedances Z1 and Z2 may becalculated. Z1 may correspond to an impedance of a tissue compressedand/or communicatively coupled between one or more of RF electrodes 6260and electrical contact 6264. Further, Z2 may correspond to an impedanceof the tissue compressed and/or communicatively coupled between one ormore of RF electrodes 6260 and electrical contact 6266. Applying theformulas Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding todifferent compressions of a tissue compressed by an end-effector 6262may be calculated. In example, the impedances Z1 and Z2 may becalculated by the impedance calculator 6272. The impedances Z1 and Z2may be used to calculate various compression levels of the tissue.

Referring now to FIG. 69, a frequency graph 6290 is shown. The frequencygraph 6290 shows a frequency modulation to nest two RF signals. The twoRF signals may be nested before reaching RF electrodes at anend-effector as described above. For example, an RF signal withFrequency 1 and an RF signal with Frequency 2 may be nested together.Referring now to FIG. 70, the resulting nested RF signal is shown infrequency graph 6300. The compound signal shown in frequency graph 6300includes the two RF signals of frequency graph 6290 compounded.Referring now to FIG. 71, a frequency graph 6310 is shown. Frequencygraph 6310 shows the RF signals with Frequencies 1 and 2 after beingfiltered (by, e.g., filters 6268 and 6270). The resulting RF signals canbe used to make separate impedance calculations or measurements on areturn path, as described above.

In one aspect, filters 6268 and 6270 may be High Q filters such that thefilter range may be narrow (e.g., Q=10). Q may be defined by the Centerfrequency (Wo)/Bandwidth (BW) where Q=Wo/BW. In one example, Frequency 1may be 150 kHz and Frequency 2 may be 300 kHz. A viable impedancemeasurement range may be 100 kHz-20 MHz. In various examples, othersophisticated techniques, such as correlation, quadrature detection,etc., may be used to separate the RF signals.

Using one or more of the techniques and features described herein, asingle energized electrode on a staple cartridge or an isolated knife ofan end-effector may be used to make multiple tissue compressionmeasurements simultaneously. If two or more RF signals are overlaid ormultiplexed (or nested or modulated), they may be transmitted down asingle power side of the end-effector and may return on either thechannel frame or the anvil of the end-effector. If a filter were builtinto the anvil and channel contacts before they join a common returnpath, the tissue impedance represented by both paths could bedifferentiated. This may provide a measure of vertical tissue vs lateraltissue compression. This approach also may provide proximal and distaltissue compression depending on placement of the filters and location ofthe metallic return paths. A frequency generator and signal processormay be located on one or more chips on a circuit board or a sub board(which may already exist in an endocutter).

In various aspects, the present disclosure provides techniques formonitoring the speed and precision incrementing of the drive motor inthe instrument 10 (described in connection with FIGS. 1-29). In oneexample, a magnet can be placed on a planet frame of one of the stagesof gear reduction with an inductance sensor on the gear housing. Inanother example, placing the magnet and magnetic field sensor on thelast stage would provide the most precise incremental movementmonitoring.

Conventional motor control systems employ encoders to detect thelocation and speed of the motor in hand held battery poweredendosurgical instruments such as powered endocutter/stapler devices.Precision operation of endocutter/stapler devices relies in part on theability to verify the motor operation under load. Simple sensorimplementations may be employed to achieve verify the motor operationunder load.

Accordingly, the present disclosure includes a magnetic body on one ofthe planetary carriers of a gear reduction system or employs brushlessmotor technology. Both approaches involve the placement of an inductancesensor on the outside housing of the motor or planetary gear system. Inthe case of a brushless motor, there are electromagnetic field coils(windings, inductors, etc.) arrayed radially around the center magneticshaft of the motor. The coils are sequentially activated and deactivatedto drive the central motor shaft. One or more inductance sensors can beplaced outside of the motor and adjacent to at least some of the coilsto sense the activation/deactivation cycles of the motor windings todetermine the number times the shaft has been rotated. Alternatively, apermanent magnet can be placed on one of the planetary carriers and theinductance sensor can be placed adjacent to the radial path of theplanetary carrier to measure the number of times that stage of the geartrain is rotated. This implementation can be applied to any rotationalcomponents in the system with increasingly more resolution possible inregions with a relatively large number of rotations during function, oras the rotational components become closer (in terms of number ofconnections) to the end effector depending on the design. The gear trainsensing method may be preferred since it actually measures rotation ofone of the stages whereas the motor sensing method senses the number oftimes the motor has been commanded to energize, rather than the actualshaft rotation. For example, if the motor is stalled under high load,the motor sensing method would not be able to detect the lack ofrotation because it senses only the energizing cycles not shaftrotation. Nevertheless, both techniques can be employed in a costeffective manner to sense motor rotation.

During stapling, for example, tissue is firmly clamped between opposingjaws before a staple is driven into the clamped tissue. Tissuecompression during clamping can cause fluid to be displaced from thecompressed tissue, and the rate or amount of displacement variesdepending on tissue type, tissue thickness, the surgical operation(e.g., clamping pressure and clamping time). In various instances, fluiddisplacement between the opposing jaws of an end effector may contributeto malformation (e.g., bending) of staples between the opposing jaws.Accordingly, in various instances, it may be desirable to control thefiring stroke, e.g., to control the firing speed, in relationship to thedetected fluid flow, or lack thereof, intermediate opposing jaws of asurgical end effector.

Accordingly, also provided herein are methods, devices, and systems formonitoring speed and incremental movement of a surgical instrument drivetrain, which in turn provides information about the operational velocityof the device (e.g., jaw closure, stapling). In accordance with thepresent examples, the instrument 10 (FIGS. 1-4) does not include a motorencoder. Rather, the instrument 10 is equipped with a motor 7012 shownin FIG. 72, which illustrates a speed sensor assembly for a power train7010 of the motor 7012, in accordance with an illustrative example. Thespeed sensor assembly can include a motor 7012 having an output shaft7014 that is coupled directly or indirectly to a drive shaft. In someexamples, the output shaft is connected to a gear reduction assembly,such as the planetary gear train 7020 shown in FIG. 72.

With continued reference to FIG. 72, the speed sensor assembly furtherincludes at least one sensor 7016 that detects the rotational speed ofany suitable component of the system. For example, the sensor may be aproximity sensor, such as an induction sensor, which detects movement ofone or more detectable elements 7018 affixed to any rotating part of thegear reduction assembly. In FIG. 72, which is exemplary, the detectableelement is affixed to the last stage annular gear 7034 c and the sensoris positioned adjacent the radial path of the detectable element so asto detect movement of the detectable element. FIG. 72 is exemplaryonly—rotating components vary depending on design—and the sensor(s) canbe affixed to any rotating component of the gear reduction assembly. Forexample, in another example, a detectable element is associated with thecarrier gear of the final stage or even the drive gear. In someexamples, a detectable element is located outside of the gear reductionassembly, such as on the driveshaft between gear reduction assembly andthe end effector. In some example, a detectable element is located on arotating component in the final gear reduction at the end effector.

With continued reference to FIG. 72, in one aspect motor 7012 isrotationally coupled to a gear reduction assembly, such as a planetarygear train 7020. However, any suitable gear reduction or transmissioncan be used and/or the motor can be coupled directly to a drive shaft(e.g., direct drive). The planetary gear train can include 1, 2, 3, 4,5, or more stages. The planetary gear train illustrated in FIG. 72 hasthree stages. The planetary gear train is driven by a sun gear (7042 inFIG. 73) attached directly or indirectly to the motor output shaft 7014.The sun gear drives one or more first stage planet gears 7032 a, whichin turn engage a first stage annular gear 7034 a. Any number of planetgears can be used such as, for example, 1, 2, 3, 4, 5 or more planetgears. First stage planet gears 7032 a communicate with a first stagecarrier 7036 a, which includes or connects to a second stage sun gear(7038 a in FIG. 73) that drives the second stage.

Similar to the first stage, the second stage includes one or more planetgears 7032 b, an annular gear 7034 b, and a carrier 7036 b that includesor connects to a third stage sun gear (7038 b in FIG. 73) that drivesthe third stage. Likewise, the third stage includes one or more planetgears 7032 c, an annular gear 7034 c, and a carrier 7036 c. The finalstage in the planetary gear train assembly is connected to a drive gear7040, which can be the final effector in the gear reduction assembly,depending on design. The use of three planetary gear stages is exemplaryonly. Any suitable type of gear reduction assembly can be used inaccordance with the present disclosure.

The sensor 7016 can be mounted in or near the gear reduction assemblyin, near, or adjacent the radial path of detectable element 7018. Thesensor can be any suitable sensor type capable of detecting rotationalspeed without an encoder. The sensor is used in conjunction with adetectable element capable of being detected by the sensor. For example,in some examples, the sensor is an inductance sensor and the detectableelement is a metallic element. The inductance sensor can be configuredto detect a change in inductance caused by a metallic object or magnetpassing adjacent the inductive sensor. In some examples, the sensor is amagnetic field sensor, and the detectable element is a magnetic element.A magnetic field sensor can be configured to detect changes in amagnetic field surrounding the magnetic field sensor caused by themovement of the magnetic element.

Detectable elements can be affixed or integral with any rotating part orparticular stage of the gear reduction assembly to measure the number oftimes that the part or stage rotates. For example, a single detectableelement could be placed on drive gear 7040. Each complete rotation ofthe drive gear would cause the detectable element to pass the sensor onetime, resulting in one detected rotation. In some examples, multipledetectable elements 7018 can be used within the same gear reductionassembly, by placing a plurality of detectable elements (e.g., 2, 3, 4,5 or more) on the same component (e.g., a gear) and/or by placing one ormore detectable elements on a plurality of different components (e.g.,on two different gears). Placing multiple sensors equally spaced on asingle component can provide refined information about incrementalrotations. Similarly, resolution of speed monitoring can be increased byplacing a detectable element(s) on a component that rotates more quicklyrelative to other components and/or by placing the detectable elementcloser (in terms of number of connections) to the end effector dependingon the design. Using multiple detectable elements on differentcomponents provides a redundant, fail-safe system should one sensor ordetectable element fail.

Sensors should be located close enough to detectable elements to ensurethat each revolution of a detectable element is captured by itsassociated sensor. Multiple sensors can be placed in the same radialpath of a detectable element. In addition, if detectable elements areplaced on a plurality of different components (e.g., two differentgears), a sensor can be placed adjacent the radial path of eachdetectable element. The sensor 7016 is in data communication with acontroller 7011 such as the microcontroller 1500 (FIG. 19) ormicrocontroller 2006 (FIGS. 21A, 21B), processor 2104 (FIG. 22), orcontroller 2606 and 3017 shown in FIGS. 27-29, which is programmed totranslate the number and/or rate of detection events into a speedreading useful to the user, such as using the speed indicator displayshown in FIGS. 88-90.

FIG. 73 shows a longitudinal cross section through plane A of FIG. 72.Clearly visible in FIG. 73 is sun gear 7042 coupled to output shaft7014.

FIG. 74 illustrates a speed sensor assembly for 7050 for directlysensing the rotational speed of a brushless motor 7060, in accordancewith an illustrative aspect. A brushless motor typically compriseselectromagnetic field coils 7062, 7064 arrayed radially around a centralmagnetic shaft (7066 in FIG. 75). Negative 7062 and positive 7064 coilsare alternately arranged around the central magnetic shaft, and thesecoils are sequentially activated and deactivated to drive the centralmagnetic shaft. One or more sensors 7016 can be placed adjacent thesecoils on the outside of the motor to monitor motor speed. The sensorinduction field 7068 is affected each time an electromagnetic field coilpasses the sensor. The sensor is in data communication with a controller7011, such as the microcontroller 1500 (FIG. 19) or microcontroller 2006(FIGS. 21A, 21B), processor 2104 (FIG. 22), or controller 2606 and 3017shown in FIGS. 27-29, for example, which is programmed to translate thenumber and/or rate of detection events into a speed reading useful tothe user, such as using a speed indicator display shown in FIGS. 88-90.

If the motor stalls, for example under high load, the sensor 7016 maystill detect activation of the coils, which the sensor 7016 wouldinterpret as motor rotation even though the motor is stalled. As aresult, under certain operational circumstances, motor speed could be aninaccurate readout for operational tool speed. In one example, speed ismeasured using one or more sensors 7016 on the gear reduction assemblybecause this measures the actual speed of the gear assembly, or a stageof the gear assembly, rather than the speed of the motor. In addition,the closer the detectable element(s) and associated sensor(s) are to theend effector, the more likely the sensed speed accurately reflectsoperational tool speed. The ability to verify motor operation under loadis important for precision operation of surgical instruments, such asstaplers.

FIG. 75 illustrates a transverse cross section through plane B of themotor assembly shown in FIG. 74. The central magnetic shaft 7066 isvisible in FIG. 75.

Sensor 7016 is in data communication with a controller 7011, such as themicrocontroller 1500 (FIG. 19) or microcontroller 2006 (FIGS. 21A, 21B),processor 2104 (FIG. 22), or controller 2606 and 3017 shown in FIGS.27-29, which is programmed to translate the number and/or rate ofdetection events into a speed reading useful to the user. The controller7011 also can regulate motor speed to ensure safe operating parametersand/or to ensure that a constant speed and/or acceleration aremaintained for particular surgical applications.

Various functions may be implemented utilizing the circuitry previouslydescribed, For example, the motor may be controlled with a motorcontroller 7011 similar those described in connection with FIGS. 21A,21B, 24, 25, 28A, 28B, and 29, where the encoder is replaced with themonitoring speed control and precision incrementing of motor systems forpowered surgical instruments described in connection with FIGS. 72-75.For example, the position encoder 2340 shown in FIG. 24 can be replacedwith the sensor 7016 shown in FIGS. 72-75 coupled to the microcontroller2306 in FIG. 24. Similarly, the position encoder 2440 shown in FIG. 25can be replaced with the sensor 7016 shown in FIGS. 72-75 coupled to themicrocontroller 2406 in FIG. 25.

In one aspect, the present disclosure provides an instrument 10(described in connection with FIGS. 1-29) configured with varioussensing systems. Accordingly, for conciseness and clarity the details ofoperation and construction will not be repeated here. In one aspect, thesensing system includes a viscoelasticity/rate of change sensing systemto monitor knife acceleration, rate of change of impedance, and rate ofchange of tissue contact. In one example, the rate of change of knifeacceleration can be used as a measure of for tissue type. In anotherexample, the rate of change of impedance can be measures with a pulsesensor ad can be employed as a measure for compressibility. Finally, therate of change of tissue contact can be measured with a sensor based onknife firing rate to measure tissue flow.

The rate of change of a sensed parameter or stated otherwise, how muchtime is necessary for a tissue parameter to reach an asymptotic steadystate value, is a separate measurement in itself and may be morevaluable than the sensed parameter it was derived from. To enhancemeasurement of tissue parameters such as waiting a predetermined amountof time before making a measurement, the present disclosure provides anovel technique for employing the derivate of the measure such as therate of change of the tissue parameter.

The derivative technique or rate of change measure becomes most usefulwith the understanding that there is no single measurement that can beemployed alone to dramatically improve staple formation. It is thecombination of multiple measurements that make the measurements valid.In the case of tissue gap it is helpful to know how much of the jaw iscovered with tissue to make the gap measure relevant. Rate of changemeasures of impedance may be combined with strain measurements in theanvil to relate force and compression applied to the tissue graspedbetween the jaw members of the end effector such as the anvil and thestaple cartridge. The rate of change measure can be employed by theendosurgical device to determine the tissue type and not merely thetissue compression. Although stomach and lung tissue sometimes havesimilar thicknesses, and even similar compressive properties when thelung tissue is calcified, an instrument may be able to distinguish thesetissue types by employing a combination of measurements such as gap,compression, force applied, tissue contact area, and rate of change ofcompression or rate of change of gap. If any of these measurements wereused alone, the endosurgical it may be difficult for the endosurgicaldevice to distinguish one tissue type form another. Rate of change ofcompression also may be helpful to enable the device to determine if thetissue is “normal” or if some abnormality exists. Measuring not only howmuch time has passed but the variation of the sensor signals anddetermining the derivative of the signal would provide anothermeasurement to enable the endosurgical device to measure the signal.Rate of change information also may be employed in determining when asteady state has been achieved to signal the next step in a process. Forexample, after clamping the tissue between the jaw members of the endeffector such as the anvil and the staple cartridge, when tissuecompression reaches a steady state (e.g., about 15 seconds), anindicator or trigger to start firing the device can be enabled.

Also provided herein are methods, devices, and systems for timedependent evaluation of sensor data to determine stability, creep, andviscoelastic characteristics of tissue during surgical instrumentoperation. A surgical instrument 10, such as the stapler illustrated inFIG. 1, can include a variety of sensors for measuring operationalparameters, such as jaw gap size or distance, firing current, tissuecompression, the amount of the jaw that is covered by tissue, anvilstrain, and trigger force, to name a few. These sensed measurements areimportant for automatic control of the surgical instrument and forproviding feedback to the clinician.

The examples shown in connection with FIGS. 52-71 may be employed tomeasure the various derived parameters such as gap distance versus time,tissue compression versus time, and anvil strain versus time. Motorcurrent may be monitored employing the current sensor 2312 in serieswith the battery 2308 as described in connection with FIG. 24, thecurrent sensor 2412 in series with the battery 2408 shown in FIG. 25, orthe current sensor 3026 in FIG. 29.

Turning now to FIG. 76, a motor-driven surgical cutting and fasteninginstrument 8010 is depicted that may or may not be reused. Themotor-driven surgical cutting and fastening instrument 8010 is similarlyconstructed and equipped as the motor-driven surgical cutting andfastening instrument 10 described in connection with FIGS. 1-29. In theexample illustrated in FIG. 76, the instrument 8010 includes a housing8012 that comprises a handle assembly 8014 that is configured to begrasped, manipulated and actuated by the clinician. The housing 8012 isconfigured for operable attachment to an interchangeable shaft assembly8200 that has a surgical end effector 8300 operably coupled thereto thatis configured to perform one or more surgical tasks or procedures. Sincethe motor-driven surgical cutting and fastening instrument 8010 issimilarly constructed and equipped as the motor-driven surgical cuttingand fastening instrument 10 described in connection with FIGS. 1-29, forconciseness and clarity the details of operation and construction willnot be repeated here.

The housing 8012 depicted in FIG. 76 is shown in connection with aninterchangeable shaft assembly 8200 that includes an end effector 8300that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 8304 therein.The housing 8012 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing8012 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

FIG. 76 illustrates the surgical instrument 8010 with an interchangeableshaft assembly 8200 operably coupled thereto. In the illustratedarrangement, the handle housing forms a pistol grip portion 8019 thatcan be gripped and manipulated by the clinician. The handle assembly8014 operably supports a plurality of drive systems therein that areconfigured to generate and apply various control motions tocorresponding portions of the interchangeable shaft assembly that isoperably attached thereto. Trigger 8032 is operably associated with thepistol grip for controlling various of these control motions.

With continued reference to FIG. 76, the interchangeable shaft assembly8200 includes a surgical end effector 8300 that comprises an elongatedchannel 8302 that is configured to operably support a staple cartridge8304 therein. The end effector 8300 may further include an anvil 8306that is pivotally supported relative to the elongated channel 8302.

The inventors have discovered that derived parameters can be even moreuseful for controlling a surgical instrument, such as the instrumentillustrated in FIG. 76, than the sensed parameter(s) upon which thederived parameter is based. Non-limiting examples of derived parametersinclude the rate of change of a sensed parameter (e.g., jaw gapdistance) and how much time elapses before a tissue parameter reaches anasymptotic steady state value (e.g., 15 seconds). Derived parameters,such as rate of change, are particularly useful because theydramatically improve measurement accuracy and also provide informationnot otherwise evident directly from sensed parameters. For example,impedance (i.e., tissue compression) rate of change can be combined withstrain in the anvil to relate compression and force, which enables themicrocontroller to determine the tissue type and not merely the amountof tissue compression. This example is illustrative only, and anyderived parameters can be combined with one or more sensed parameters toprovide more accurate information about tissue types (e.g., stomach vs.lung), tissue health (calcified vs. normal), and operational status ofthe surgical device (e.g., clamping complete). Different tissues haveunique viscoelastic properties and unique rates of change, making theseand other parameters discussed herein useful indicia for monitoring andautomatically adjusting a surgical procedure.

FIGS. 78A-78E show exemplary sensed parameters as well as parametersderived therefrom. FIG. 78A is an illustrative graph showing gapdistance over time, where the gap is the space between the jaws beingoccupied by clamped tissue. The vertical (y) axis is distance and thehorizontal (x) axis is time. Specifically, referring to FIGS. 76 and 77,the gap distance 8040 is the distance between the anvil 8306 and theelongate channel 8302 of the end effector. In the open jaw position, attime zero, the gap 8040 between the anvil 8306 and the elongate memberis at its maximum distance. The width of the gap 8040 decreases as theanvil 8306 closes, such as during tissue clamping. The gap distance rateof change can vary because tissue has non-uniform resiliency. Forexample, certain tissue types may initially show rapid compression,resulting in a faster rate of change. However, as tissue is continuallycompressed, the viscoelastic properties of the tissue can cause the rateof change to decrease until the tissue cannot be compressed further, atwhich point the gap distance will remain substantially constant. The gapdecreases over time as the tissue is squeezed between the anvil 8306 andthe staple cartridge 8304 of the end effector 8040. The one or moresensors described in connection with FIGS. 50-68 and FIG. 84 may beadapted and configured to measure the gap distance “d” between the anvil8306 and the staple cartridge 8304 over time “t” as representedgraphically in FIG. 78A. The rate of change of the gap distance “d” overtime “t” is the Slope of the curve shown in FIG. 78A, where Slope=Δd/Δt.

FIG. 78B is an illustrative graph showing firing current of the endeffector jaws. The vertical (y) axis is current and the horizontal (x)axis is time. As discussed herein, the surgical instrument and/or themicrocontroller, as shown in FIGS. 21-29, thereof can include a currentsensor that detects the current utilized during various operations, suchas clamping, cutting, and/or stapling tissue. For example, when tissueresistance increases, the instrument's electric motor can require morecurrent to clamp, cut, and/or staple the tissue. Similarly, ifresistance is lower, the electric motor can require less current toclamp, cut, and/or staple the tissue. As a result, firing current can beused as an approximation of tissue resistance. The sensed current can beused alone or more preferably in conjunction with other measurements toprovide feedback about the target tissue. Referring still to FIG. 78B,during some operations, such as stapling, firing current initially ishigh at time zero but decreases over time. During other deviceoperations, current may increase over time if the motor draws morecurrent to overcome increasing mechanical load. In addition, the rate ofchange of firing current is can be used as an indicator that the tissueis transitioning from one state to another state. Accordingly, firingcurrent and, in particular, the rate of change of firing current can beused to monitor device operation. The firing current decreases over timeas the knife cuts through the tissue. The rate of change of firingcurrent can vary if the tissue being cut provides more or lessresistance due to tissue properties or sharpness of the knife 8305 (FIG.77). As the cutting conditions vary, the work being done by the motorvaries and hence will vary the firing current over time. A currentsensor may be may be employed to measure the firing current over timewhile the knife 8305 is firing as represented graphically in FIG. 78B.For example, the motor current may be monitored employing the currentsensor 2312 in series with the battery 2308 as described in connectionwith FIG. 24, the current sensor 2412 in series with the battery 2408shown in FIG. 25, or the current sensor 3026 shown in FIG. 29. Thecurrent sensors 2312, 2314, 3026 may be adapted and configured tomeasure the motor firing current “i” over time “t” as representedgraphically in FIG. 78B. The rate of change of the firing current “i”over time “t” is the Slope of the curve shown in FIG. 78B, whereSlope=Δi/At.

FIG. 78C is an illustrative graph of impedance over time. The vertical(y) axis is impedance and the horizontal (x) axis is time. At time zero,impedance is low but increases over time as tissue pressure increasesunder manipulation (e.g., clamping and stapling). The rate of changevaries over time as because as the tissue between the anvil 8306 and thestaple cartridge 8304 of the end effector 8040 is severed by the knifeor is sealed using RF energy between electrodes located between theanvil 8306 and the staple cartridge 8304 of the end effector 8040. Forexample, as the tissue is cut the electrical impedance increases andreaches infinity when the tissue is completely severed by the knife.Also, if the end effector 8040 includes electrodes coupled to an RFenergy source, the electrical impedance of the tissue increases asenergy is delivered through the tissue between the anvil 8306 and thestaple cartridge 8304 of the end effector 8040. The electrical impedanceincrease as the energy through the tissue dries out the tissue byvaporizing moistures in the tissue. Eventually, when a suitable amountof energy is delivered to the tissue, the impedance increases to a veryhigh value or infinity when the tissue is severed. In addition, asillustrated in FIG. 78C, different tissues can have unique compressionproperties, such as rate of compression, that distinguish tissues. Thetissue impedance can be measured by driving a sub-therapeutic RF currentthrough the tissue grasped between the first and second jaw members9014, 9016. One or more electrodes can be positioned on either or boththe anvil 8306 and the staple cartridge 8304. The tissuecompression/impedance of the tissue between the anvil 8306 and thestaple cartridge 8304 can be measured over time as representedgraphically in FIG. 78C. The sensors described in connection with FIGS.50-68 and 84 may be adapted and configured to measure tissuecompression/impedance. The sensors may be adapted and configured tomeasure tissue impedance “Z” over time “t” as represented graphically inFIG. 78C. The rate of change of the tissue impedance “Z” over time “t”is the Slope of the curve shown in FIG. 78C, where Slope=ΔZ/Δt.

FIG. 78D is an illustrative graph of anvil 8306 (FIGS. 76, 77) strainover time. The vertical (y) axis is strain and the horizontal (x) axisis time. During stapling, for example, anvil 8306 strain initially ishigh but decreases as the tissue reaches a steady state and exerts lesspressure on the anvil 8306. The rate of change of anvil 8306 strain canbe measured by a pressure sensor or strain gauge positioned on either orboth the anvil 8306 and the staple cartridge 8304 (FIGS. 76, 77) tomeasure the pressure or strain applied to the tissue grasped between theanvil 8306 and the staple cartridge 8304. The anvil 8306 strain can bemeasured over time as represented graphically in FIG. 78D. The rate ofchange of strain “S” over time “t” is the Slope of the curve shown inFIG. 78D, where Slope=ΔS/Δt.

FIG. 78E is an illustrative graph of trigger force over time. Thevertical (y) axis is trigger force and the horizontal (x) axis is time.In certain examples, trigger force is progressive, to provide theclinician tactile feedback. Thus, at time zero, trigger 8020 (FIG. 76)pressure may be at its lowest and trigger pressure may increase untilcompletion of an operation (e.g., clamping, cutting, or stapling). Therate of change trigger force can be measured by a pressure sensor orstrain gauge positioned on the trigger 8302 of the handle 8019 of theinstrument 8010 (FIG. 76) to measure the force required to drive theknife 8305 (FIG. 77) through the tissue grasped between the anvil 8306and the staple cartridge 8304. The trigger 8032 force can be measuredover time as represented graphically in FIG. 78E. The rate of change ofstrain trigger force “F” over time “t” is the Slope of the curve shownin FIG. 78E, where Slope=ΔF/Δt.

For example, stomach and lung tissue can be differentiated even thoughthese tissues can have similar thicknesses, and can have similarcompressive properties if the lung tissue is calcified. Stomach and lungtissues can be distinguished by analyzing jaw gap distance, tissuecompression, force applied, tissue contact area, compression rate ofchange, and jaw gap rate of change. For example, FIG. 79 shows a graphof tissue pressure “P” versus tissue displacement for various tissues.The vertical (y) axis is tissue pressure and the horizontal (x) axis istissue displacement. When tissue pressure reaches a predeterminedthreshold, such as 50-100 pounds per square inch (psi), the amount oftissue displacement as well as the rate of tissue displacement beforereaching the threshold can be used to differentiate tissues. Forinstance, blood vessel tissue reaches the predetermined pressurethreshold with less tissue displacement and with a faster rate of changethan colon, lung, or stomach tissue. In addition, the rate of change(tissue pressure over displacement) for blood vessel tissue is nearlyasymptotic at a threshold of 50-100 psi, whereas the rate of change forcolon, lung, and stomach is not asymptotic at a threshold of 50-100 psi.As will be appreciated, any pressure threshold can be used such as, forexample, between 1 and 1000 psi, more preferably between 10 and 500 psi,and more preferably still between 50 and 100 psi. In addition, multiplethresholds or progressive thresholds can be used to provide furtherresolution of tissue types that have similar viscoelastic properties.

Compression rate of change also can enable the microcontroller todetermine if the tissue is “normal” or if some abnormality exists, suchas calcification. For example, referring to FIG. 80, compression ofcalcified lung tissue follows a different curve than compression ofnormal lung tissue. Tissue displacement and rate of change of tissuedisplacement therefore can be used to diagnose and/or differentiatecalcified lung tissue from normal lung tissue.

In addition, certain sensed measurements may benefit from additionalsensory input. For example, in the case of jaw gap, knowing how much ofthe jaw is covered with tissue can make the gap measurement more usefuland accurate. If a small portion of the jaw is covered in tissue, tissuecompression may appear to be less than if the entire jaw is covered intissue. Thus, the amount of jaw coverage can be taken into account bythe microcontroller when analyzing tissue compression and other sensedparameters.

In certain circumstances, elapsed time also can be an importantparameter. Measuring how much time has passed, together with sensedparameters, and derivative parameters (e.g., rate of change) providesfurther useful information. For example, if jaw gap rate of changeremains constant after a set period of time (e.g., 5 seconds), then theparameter may have reached its asymptotic value.

Rate of change information also is useful in determining when a steadystate has been achieved, thus signaling a next step in a process. Forexample, during clamping, when tissue compression reaches a steadystate—e.g., no significant rate of change occurs after a set period oftime—the microcontroller can send a signal to the display alerting theclinician to start the next step in the operation, such as staplefiring. Alternatively, the microcontroller can be programmed toautomatically start the next stage of operation (e.g., staple firing)once a steady state is reached.

Similarly, impedance rate of change can be combined with strain in theanvil to relate force and compression. The rate of change would allowthe device to determine the tissue type rather than merely measure thecompression value. For example, stomach and lung sometimes have similarthicknesses, and even similar compressive properties if the lung iscalcified.

The combination of one or more sensed parameters with derived parametersprovides more reliable and accurate assessment of tissue types andtissue health, and allows for better device monitoring, control, andclinician feedback.

Turning briefly to FIG. 84, the end effector 9012 is one aspect of theend effector 8300 (FIG. 76) that may be adapted to operate with surgicalinstrument 8010 (FIG. 76) to measure the various derived parameters suchas gap distance versus time, tissue compression versus time, and anvilstrain versus time. Accordingly, the end effector 9012 shown in FIG. 84may include one or more sensors configured to measure one or moreparameters or characteristics associated with the end effector 9012and/or a tissue section captured by the end effector 9012. In theexample illustrated in FIG. 84, the end effector 9012 comprises a firstsensor 9020 and a second sensor 9026. In various examples, the firstsensor 9020 and/or the second sensor 9026 may comprise, for example, amagnetic sensor such as, for example, a magnetic field sensor, a straingauge, a pressure sensor, a force sensor, an inductive sensor such as,for example, an eddy current sensor, a resistive sensor, a capacitivesensor, an optical sensor, and/or any other suitable sensor formeasuring one or more parameters of the end effector 9012.

In certain instances, the first sensor 9020 and/or the second sensor9026 may comprise, for example, a magnetic field sensor embedded in thefirst jaw member 9014 and configured to detect a magnetic fieldgenerated by a magnet 9024 embedded in the second jaw member 9016 and/orthe staple cartridge 9018. The strength of the detected magnetic fieldmay correspond to, for example, the thickness and/or fullness of a biteof tissue located between the jaw members 9014, 9016. In certaininstances, the first sensor 9020 and/or the second sensor 9026 maycomprise a strain gauge, such as, for example, a micro-strain gauge,configured to measure the magnitude of the strain in the anvil 9014during a clamped condition. The strain gauge provides an electricalsignal whose amplitude varies with the magnitude of the strain.

In some aspects, one or more sensors of the end effector 9012 such as,for example, the first sensor 9020 and/or the second sensor 9026 maycomprise a pressure sensor configured to detect a pressure generated bythe presence of compressed tissue between the jaw members 9014, 9016. Insome examples, one or more sensors of the end effector 9012 such as, forexample, the first sensor 9020 and/or the second sensor 9026 areconfigured to detect the impedance of a tissue section located betweenthe jaw members 9014, 9016. The detected impedance may be indicative ofthe thickness and/or fullness of tissue located between the jaw members9014, 9016.

In one aspect, one or more of the sensors of the end effector 9012 suchas, for example, the first sensor 9012 is configured to measure the gap9022 between the anvil 9014 and the second jaw member 9016. In certaininstances, the gap 9022 can be representative of the thickness and/orcompressibility of a tissue section clamped between the jaw members9014, 9016. In at least one example, the gap 9022 can be equal, orsubstantially equal, to the thickness of the tissue section clampedbetween the jaw members 9014, 9016. In one example, one or more of thesensors of the end effector 9012 such as, for example, the first sensor9020 is configured to measure one or more forces exerted on the anvil9014 by the second jaw member 9016 and/or tissue clamped between theanvil 9014 and the second jaw member 9016. The forces exerted on theanvil 9014 can be representative of the tissue compression experiencedby the tissue section captured between the jaw members 9014, 9016. Inone embodiment, the gap 9022 between the anvil 9014 and the second jawmember 9016 can be measured by positioning a magnetic field sensor onthe anvil 9014 and positioning a magnet on the second jaw member 9016such that the gap 9022 is proportional to the signal detected by themagnetic field sensor and the signal is proportional to the distancebetween the magnet and the magnetic field sensor. It will be appreciatedthat the location of the magnetic field sensor and the magnet may beswapped such that the magnetic field sensor is positioned on the secondjaw member 9016 and the magnet is placed on the anvil 9014.

One or more of the sensors such as, for example, the first sensor 9020and/or the second sensor 9026 may be measured in real-time during aclamping operation. Real-time measurement allows time based informationto be analyzed, for example, by a processor, and used to select one ormore algorithms and/or look-up tables for the purpose of assessing, inreal-time, a manual input of an operator of the surgical instrument9010. Furthermore, real-time feedback can be provided to the operator toassist the operator in calibrating the manual input to yield a desiredoutput.

In various aspects, the present disclosure provides an instrument 10 (asdescribed in connection with FIGS. 1-29) configured to provide rate andcontrol feedback to the surgeon. In one example, the instrument 10(FIGS. 1-4) comprises an energy device to provide rate/impedancefeedback. In another example, the instrument 10 provides time dependencysuch as time between steps and/or rate of firing. In another example,the instrument 10 is configured with a display that the surgeon canmonitor for error resolution. In one implementation, the display may bea flexible roll up display is contained within handle (no externaldisplay) in the event of failure user unrolls display to determine stepsto release.

The present disclosure provides a novel feedback system for surgicalinstruments to enable the surgeon to balance the motor controlled speedof knife actuation with the thickness and stiffness of the tissuegrasped between the jaw members of the end effector such as the anviland the staple cartridge. The present technique for adjusting the knifeactuation speed based on the thickness of the tissue and tissue flow canimprove the consistency of staple formation to form a stapled seal.

Accordingly, the present disclosure provides the surgeon a feedbackmechanism on the shaft or the handle of the endosurgical device. Thefeedback comprises a combination of the speed of the advancement of theknife, the tissue compression (impedance), the tissue gap (d), and forceto advance (motor current draw). This combination can be displayed on anindicator comprising multiple zones, such as 5-9 zones, for example,with the mid zone indicating the most ideal speed for the force andtissue compression being handled. The more compression the slower thespeed to keep the indicator balanced in the center. This would provide asurgeon a repeatable relative measure to judge thickness and tissue flowand the surgeon could then decide how far out of balance theendosurgical device can be operated within certain conditions in orderto achieve overall good results. The present feedback mechanism alsowould provide the surgeon a good evaluation when the tissue and/orfiring conditions are out of the ordinary to enable the surgeon toproceed cautiously with the operation during that particular firing. Thefeedback mechanism also can enable the surgeon to learn the besttechnique for firing the endosurgical device with limited to no inservicing.

Turning to the figures, FIG. 81 illustrates a surgical instrument 9010.The surgical instrument 9010 is similar in many respects to othersurgical instruments described in the present disclosure. For example,the surgical instrument 9010 is similarly constructed and equipped asthe motor-driven surgical cutting and fastening instrument 10 describedin connection with FIGS. 1-29. Therefore, for conciseness and claritythe details of operation and construction will not be repeated here.Accordingly, the surgical instrument 9010, like other surgicalinstruments described in the present disclosure, comprises an endeffector 9012. In the example illustrated in FIGS. 81-82, the endeffector 9012 comprises a first jaw member, or anvil, 9014 pivotallycoupled to a second jaw member 9016 to capture tissue between the firstjaw member 9014 and the second jaw member 9016. The second jaw member9016 is configured to receive a staple cartridge 9018 therein. Thestaple cartridge 9018 comprises a plurality of staples 9042. Theplurality of staples 9402 is deployable from the staple cartridge 9018during a surgical operation.

In alternative aspects, the end effector 9012 can be configured to sealtissue captured between the first jaw member 9014 and the second jawmember 9016. For example, the first jaw member 9014 and the second jawmember 9016 may each include an electrically conductive member. Theelectrically conductive members may cooperate to transmit energy throughtissue captured therebetween to treat and/or seal the tissue. A powersource such as, for example, a battery can be configured to provide theenergy.

In certain instances, as illustrated in FIG. 81, the surgical instrument9010 can be a motor-driven surgical cutting and fastening instrumentthat may or may not be reused. In the illustrated example, theinstrument 9010 includes a housing 9028 that comprises a handle 9030that is configured to be grasped, manipulated and actuated by theclinician. In the example illustrated in FIG. 81, the housing 9028 isoperably coupled to a shaft assembly 9032 that has a surgical endeffector 9012 configured to perform one or more surgical tasks orprocedures.

The housing 9028 depicted in FIG. 81 is shown in connection with a shaftassembly 9032 that includes an end effector 9012 that comprises asurgical cutting and fastening device that is configured to operablysupport a surgical staple cartridge 9018 therein. The housing 9028 maybe configured for use in connection with shaft assemblies that includeend effectors that are adapted to support different sizes and types ofstaple cartridges, have different shaft lengths, sizes, and types, etc.In addition, the housing 9028 also may be effectively employed with avariety of other shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures.

Referring to FIG. 82, a non-limiting form of the end effector 9012 isillustrated. As described above, the end effector 9012 may include theanvil 9014 and the staple cartridge 9018. In this non-limiting example,the anvil 9014 is coupled to an elongate channel 9034. In addition, FIG.82 shows a firing bar 9036, configured to longitudinally translate intothe end effector 9012. A distally projecting end of the firing bar 9036can be attached to an E-beam 9038 that can, among other things, assistin spacing the anvil 9014 from a staple cartridge 9018 positioned in theelongate channel 9034 when the anvil 9014 is in a closed position. TheE-beam 9038 can also include a sharpened cutting member 9040 which canbe used to sever tissue as the E-beam 9038 is advanced distally by thefiring bar 9036. In operation, the E-beam 9038 can also actuate, orfire, the staple cartridge 9018. The staple cartridge 9018 can include aplurality of staples 9042. A wedge sled 9044 is driven distally by theE-beam 9038 to force out the staples 9042 into deforming contact withthe anvil 9012 while a cutting member 9040 of the E-beam 9038 seversclamped tissue.

In one aspect, as illustrated in FIGS. 81-83, a motor can be operablycoupled to the firing bar 9036. The motor can be powered by a powersource such as, for example, a battery 9039. The battery 9039 may supplypower to the motor 9082 to motivate the firing bar 9036 to advance theE-beam 9038 to fire the staples 9042 into tissue captured between theanvil 9014 and the staple cartridge 9018 and/or advance the cuttingmember 9040 to sever the captured tissue. Actuation of the motor 9082can be controlled by a firing trigger 9094 that is pivotally supportedon the handle 9030. The firing trigger 9094 can be depressed by anoperator of the surgical instrument 9010 to activate the motor 9082.

In one instance, the firing trigger 9094 can be depressed or actuatedbetween a plurality of positions each yielding a different output value.For example, actuating the firing trigger 9094 to a first position mayyield a first output value, and actuating the firing trigger 9094 to asecond position after the first position may yield a second output valuegreater than the first output value. In certain instances, the greaterthe firing trigger 9094 is depressed or actuated, the greater the outputvalue. In certain instances, the output is a characteristic of motion ofthe firing bar 9036 and/or the cutting member 9040. In one instance, theoutput can be the speed of the cutting member 9040 during advancement ofthe cutting member 9040 in a firing stroke. In such instance, actuatingthe firing trigger 9094 to a first position may cause the cutting member9040 to travel at a first speed, and actuating the firing trigger 9094to a second position may cause the cutting member 9040 to travel at asecond speed different from the first speed. In certain instances, thegreater the firing trigger 9094 is depressed or actuated, the greaterthe speed of travel of the cutting member 9040.

In the aspect illustrated in FIG. 83, a tracking system 9080 isconfigured to determine the position of the firing trigger 9094. Thetracking system 9080 can include a magnetic element, such as permanentmagnet 9086, for example, which is mounted to an arm 9084 extending fromthe firing trigger 9094. The tracking system 9080 can comprise one ormore sensors, such as a first magnetic field sensor 9088 and a secondmagnetic field sensor 9090, for example, which can be configured totrack the position of the magnet 9086. The sensors 9088 and 9090 cantrack the movement of the magnet 9086 and can be in signal communicationwith a microcontroller such as, for example, the microcontroller 9061(FIG. 87). With data from the first sensor 9088 and/or the second sensor9090, the microcontroller 9061 can determine the position of the magnet9086 along a predefined path and, based on that position, themicrocontroller 9061 can determine an output of the motor 9082. Incertain instances, a motor driver 9092 can be in communication with themicrocontroller 9061, and can be configured to drive the motor 9082 inaccordance with an operator's manual input as detected by the trackingsystem 9080.

In certain instances, the magnetic field sensors can be configured todetect movement of the firing trigger 9094 through a firing strokeinstead of, or in addition to, detecting discrete positions along thefiring stroke. The strength of the magnetic field generated by thepermanent magnet, as detected by the magnetic field sensors, changes asthe permanent magnet 9086 is moved with the firing trigger 9094 throughthe firing stroke. The change in the strength of the magnetic field canbe indicative of a characteristic of motion of the firing trigger 9094,which can detected by a microcontroller as a manual input.

The end effector 9012 may include one or more sensors configured tomeasure one or more parameters or characteristics associated with theend effector 9012 and/or a tissue section captured by the end effector9012. In the example illustrated in FIG. 84, the end effector 9012comprises a first sensor 9020 and a second sensor 9026. In variousexamples, the first sensor 9020 and/or the second sensor 9026 maycomprise, for example, a magnetic sensor such as, for example, amagnetic field sensor, a strain gauge, a pressure sensor, a forcesensor, an inductive sensor such as, for example, an eddy currentsensor, a resistive sensor, a capacitive sensor, an optical sensor,and/or any other suitable sensor for measuring one or more parameters ofthe end effector 9012.

In certain instances, the first sensor 9020 and/or the second sensor9026 may comprise, for example, a magnetic field sensor embedded in thefirst jaw member 9014 and configured to detect a magnetic fieldgenerated by a magnet 9024 embedded in the second jaw member 9016 and/orthe staple cartridge 9018. The strength of the detected magnetic fieldmay correspond to, for example, the thickness and/or fullness of a biteof tissue located between the jaw members 9014, 9016. In certaininstances, the first sensor 9020 and/or the second sensor 9026 maycomprise a strain gauge, such as, for example, a micro-strain gauge,configured to measure the magnitude of the strain in the anvil 9014during a clamped condition. The strain gauge provides an electricalsignal whose amplitude varies with the magnitude of the strain.

In some aspects, one or more sensors of the end effector 9012 such as,for example, the first sensor 9020 and/or the second sensor 9026 maycomprise a pressure sensor configured to detect a pressure generated bythe presence of compressed tissue between the jaw members 9014, 9016. Insome examples, one or more sensors of the end effector 9012 such as, forexample, the first sensor 9020 and/or the second sensor 9026 areconfigured to detect the impedance of a tissue section located betweenthe jaw members 9014, 9016. The detected impedance may be indicative ofthe thickness and/or fullness of tissue located between the jaw members9014, 9016.

In one aspect, one or more of the sensors of the end effector 9012 suchas, for example, the first sensor 9012 is configured to measure the gap9022 between the anvil 9014 and the second jaw member 9016. In certaininstances, the gap 9022 can be representative of the thickness and/orcompressibility of a tissue section clamped between the jaw members9014, 9016. In at least one example, the gap 9022 can be equal, orsubstantially equal, to the thickness of the tissue section clampedbetween the jaw members 9014, 9016. In one example, one or more of thesensors of the end effector 9012 such as, for example, the first sensor9020 is configured to measure one or more forces exerted on the anvil9014 by the second jaw member 9016 and/or tissue clamped between theanvil 9014 and the second jaw member 9016. The forces exerted on theanvil 9014 can be representative of the tissue compression experiencedby the tissue section captured between the jaw members 9014, 9016. Inone embodiment, the gap 9022 between the anvil 9014 and the second jawmember 9016 can be measured by positioning a magnetic field sensor onthe anvil 9014 and positioning a magnet on the second jaw member 9016such that the gap 9022 is proportional to the signal detected by themagnetic field sensor and the signal is proportional to the distancebetween the magnet and the magnetic field sensor. It will be appreciatedthat the location of the magnetic field sensor and the magnet may beswapped such that the magnetic field sensor is positioned on the secondjaw member 9016 and the magnet is placed on the anvil 9014.

One or more of the sensors such as, for example, the first sensor 9020and/or the second sensor 9026 may be measured in real-time during aclamping operation. Real-time measurement allows time based informationto be analyzed, for example, by a processor, and used to select one ormore algorithms and/or look-up tables for the purpose of assessing, inreal-time, a manual input of an operator of the surgical instrument9010. Furthermore, real-time feedback can be provided to the operator toassist the operator in calibrating the manual input to yield a desiredoutput.

FIG. 85 is a logic diagram illustrating one aspect of a process 9046 forassessing, in real-time, a manual input of an operator of the surgicalinstrument 9010 and providing real-time feedback to the operator as tothe adequacy of the manual input. In the example illustrated in FIG. 85,the process starts at step or block 9050 where one or more parameters ofthe end effector 9012 are measured. Next at step 9052, a manual input ofan operator of the surgical instrument 9010 is assessed. In one example,a value representative of the manual input is determined. Next at step9054, the determined value is evaluated or assessed for a position,rank, and/or status with respect to a desired zone or range. Themeasurement of the parameters of the end effector 9012 and thedetermined value can be employed to select or determine the position,rank, and/or status associated with the determined value. In a followingstep 9056 of the process 9046, the position, rank, and/or statusassociated with the determined value is reported to the operator of thesurgical instrument 9010. The real-time feedback allows the operator toadjust the manual input until a position, rank, and/or status within thedesired zone or range is achieved. For example, the operator may changethe manual input by increasing or decreasing the manual input whilemonitoring the real-time feedback until the position, rank, and/orstatus associated with a determined value that corresponds to a presentmanual input is within the desired zone or range.

FIG. 86 is a logic diagram illustrating one aspect of a real-timefeedback system 9060 for assessing, in real-time, a manual input 9064 ofan operator of the surgical instrument 9010 and providing to theoperator real-time feedback as to the adequacy of the manual input 9064.With reference to FIGS. 81-86, in the example illustrated in FIG. 86,the real-time feedback system 9060 is comprised of a circuit. Thecircuit includes a microcontroller 9061 comprising a processor 9062. Asensor such as, for example, the sensor 9020 is employed by theprocessor 9062 to measure a parameter of the end effector 9012. Inaddition, the processor 9062 can be configured to determine or receive avalue representative of a manual input 9064 of an operator of thesurgical instrument 9010. The manual input 9064 can be continuouslyassessed by the processor 9062 for as long as the manual input 9064 isbeing provided by the operator. The processor 9062 can be configured tomonitor a value representative of the manual input 9064. Furthermore,the processor 9062 is configured to assign, select, or determine aposition, rank, and/or status for the determined value with respect to adesired zone or range. The measurement of the parameter of the endeffector 9012 and the determined value can be employed by the processor9062 to select or determine the position, rank, and/or status associatedwith the determined value, as described in greater detail below. Achange in the manual input 9064 yields a change in the determined valuewhich, in turn, yields a change in the position, rank, and/or statusassigned to the determined value with respect to the desired zone orrange.

As illustrated in FIG. 86, the real-time feedback system 9060 mayfurther include a feedback indicator 9066 which can be adjusted betweena plurality of positions, ranks, and/or statuses inside and outside adesired zone or range. In one example, the processor 9062 may select afirst position (P1), rank, and/or status that characterizes the manualinput 9064 based on a measurement (M1) of a parameter of the endeffector 9012 and a first determined value (V1) representing a firstmanual input (I1). In certain instances, the first position (P1), rank,and/or status may fall outside the desired zone or range. In suchinstances, the operator may change the manual input 9064 from the firstmanual input (I1) to a second manual input (I2) by increasing ordecreasing the manual input 9064, for example. In response, theprocessor 9062 may adjust the feedback indicator 9066 from the firstposition (P1), rank, and/or status to a second position (P2), rank,and/or status, which characterizes the change to the manual input 9064.The processor 9062 may select the second position (P2), rank, and/orstatus based on the measurement (M1) of the parameter of the endeffector 9012 and a second determined value (V2) representing a secondmanual input (I2). In certain instances, the second position (P2), rank,and/or status may fall inside the desired zone or range. In suchinstances, the operator may maintain the second manual input (I2) for aremainder of a treatment cycle or procedure, for example.

In the aspect illustrated in FIG. 86, the microcontroller 9061 includesa storage medium such as, for example, a memory unit 9068. The memoryunit 9068 may be configured to store correlations between measurementsof one or more parameters of the end effector 9012, values representingmanual inputs, and corresponding positions, ranks, and/or statusescharacterizing the manual input 9064 with respect to a desired zone orrange. In one example, the memory unit 9068 may store the correlationbetween the measurement (M1), the first determined value (V1), and thefirst manual input (I1), and the correlation between the measurement(M1), the second determined value (V2), and the second manual input(I2). In one example, the memory unit 9068 may store an algorism, anequation, or a look-up table for determining correlations betweenmeasurements of one or more parameters of the end effector 9012, valuesrepresenting manual inputs, and corresponding positions, ranks, orstatuses with respect to a desired zone or range. The processor 9062 mayemploy such algorism, equation, and/or look-up table to characterize amanual input 9064 provided by an operator of the surgical instrument9010 and provide feedback to the operator as to the adequacy of themanual input 9064.

FIG. 87 is a logic diagram illustrating one aspect of a real-timefeedback system 9070. The system 9070 is similar in many respects to thesystem 9060. For example, like the system 9060, the system 9070 isconfigured for assessing, in real-time, a manual input of an operator ofthe surgical instrument 9010 and providing to the operator real-timefeedback as to the adequacy of the manual input. Furthermore, like thesystem 9060, the system 9070 is comprised of a circuit that may includethe microcontroller 9061.

In the aspect illustrated in FIG. 87, a strain gauge 9072, such as, forexample, a micro-strain gauge, is configured to measure one or moreparameters of the end effector 9012, such as, for example, the amplitudeof the strain exerted on the anvil 9014 during a clamping operation,which can be indicative of the tissue compression. The measured strainis converted to a digital signal and provided to the processor 9062. Aload sensor 9074 can measure the force to advance the cutting member9040 to cut tissue captured between the anvil 9014 and the staplecartridge 9018. Alternatively, a current sensor (not shown) can beemployed to measure the current drawn by the motor 9082. The forcerequired to advance the firing bar 9036 can correspond to the currentdrawn by the motor 9082, for example. The measured force is converted toa digital signal and provided to the processor 9062. A magnetic fieldsensor 9076 can be employed to measure the thickness of the capturedtissue, as described above. The measurement of the magnetic field sensor9076 is also converted to a digital signal and provided to the processor9062.

In the aspect illustrated in FIG. 87, the system 9070 further includesthe tracking system 9080 which can be configured to determine theposition of the firing trigger 9094 (FIG. 83). As described above, thefiring trigger 9094 can be depressed or actuated by moving the firingtrigger 9094 between a plurality of positions, each corresponding to oneof a plurality of values of a characteristic of motion of the firing bar9036 and/or the cutting member 9040 during a firing stroke. As describeabove, a characteristic of motion can be a speed of advancement of thefiring bar 9036 and/or the cutting member 9040 during the firing stroke.In certain instances, a motor driver 9092 can be in communication withthe microcontroller 9061, and can be configured to drive the motor 9082in accordance with an operator's manual input as detected by thetracking system 9080.

Further to the above, the system 9070 may include a feedback indicator9066. In one aspect, the feedback indicator 9066 can be disposed in thehandle 9030. Alternatively, the feedback indicator can be disposed inthe shaft assembly 9032, for example. In any event, the microcontroller9061 may employ the feedback indicator 9066 to provide feedback to anoperator of the surgical instrument 9010 with regard to the adequacy ofa manual input such as, for example, a selected position of the firingtrigger 9094. To do so, the microcontroller 9061 may assess the selectedposition of the firing trigger 9094 and/or the corresponding value ofthe speed of the firing bar 9036 and/or the cutting member 9040. Themeasurements of the tissue compression, the tissue thickness, and/or theforce required to advance the firing bar 9036, as respectively measuredby the sensors 9072, 9074, and 9076, can be used by the microcontroller9061 to characterize the selected position of the firing trigger 9094and/or the corresponding value of the speed of the firing bar 9036and/or the cutting member 9040. In one instance, the memory 9068 maystore an algorism, an equation, and/or a look-up table which can beemployed by the microcontroller 9061 in the assessment. In one example,the measurements of the sensors 9072, 9074, and/or 9076 can be used toselect or determine a position, rank, and/or a status that characterizesthe selected position of the firing trigger 9094 and/or thecorresponding value of the speed of the firing bar 9036 and/or thecutting member 9040. The determined position, rank, and/or status can becommunicated to the operator via the feedback indicator 9066.

The reader will appreciate that an optimal speed of the firing bar 9036and/or the cutting member 9040 during a firing stroke can depend onseveral parameters of the end effector 9012 such as, for example, thethickness of the tissue captured by the end effector 9012, the tissuecompression, and/or the force required to advance the firing bar 9036and, in turn, the cutting member 9040. As such, measurements of theseparameters can be leveraged by the microcontroller 9061 in assessingwhether a current speed of advancement of the cutting member 9040through the captured tissue is within an optimal zone or range.

In one aspect, as illustrated in FIGS. 88-90, the feedback indicator9066 includes a dial 9096 and a pointer 9098 movable between a pluralitypositions relative to the dial 9096. The dial 9096 is divided to definean optimal zone, a so-called “TOO FAST” zone, and a so-called “TOO SLOW”zone. The pointer 9098 can be set to one of a plurality of positionswithin the three zones. In one example, as illustrated in FIG. 88, thepointer is set to a position in the “TOO SLOW” zone to alert theoperator that a selected speed of advancement of the cutting member 9040through the tissue captured by the end effector 9012 is below an optimalor a desired zone. As described above, such a characterization of theselected speed can be performed by the microcontroller 9061 based on oneor more measurements of one or more parameters of the end effector 9012.In another example, perhaps after the operator increases the speed ofthe cutting member 9040 in response to the previous alert, the pointeris moved to a new position in the “TOO FAST” zone, as illustrated inFIG. 89, to alert the operator that a newly selected speed of thecutting member 9040 exceeds the optimal zone. The operator may continueto adjust the speed of the cutting member 9040 by adjusting the positionof the firing trigger 9094 until the pointer lands in the optimal zone,as illustrated in FIG. 90. At such point, the operator may maintain thecurrent position of the firing trigger 9094 for the remainder of thefiring stroke.

In certain instances, the dial 9096 and the pointer 9098 can be replacedwith a digital indicator. In one example, the digital indicator includesa screen that illustrates the above-identified three zones. A digitalpointer can be transitioned between a plurality of positions on thescreen to provide feedback to the operator in accordance with thepresent disclosure. In certain instances, as illustrated in FIGS. 91-93,the feedback indicator 9066 includes a plurality of zones with a middlezone indicating an optimal or ideal speed of the cutting member 9040. Inthe example illustrated in FIG. 91, nine zones are illustrated. However,in alternative examples, the feedback indicator 9066 may include five orseven zones, for example. As illustrated in FIG. 91, the plurality ofzones can be color coded. For example, the middle zone can be in green.The first two zones to the right and the first two zones to the left ofthe middle zone can be in yellow. The remaining zones can be in red. Incertain instances, as illustrated in FIG. 91, the nine zones can benumbered with the numbers −4, −3, −2, 0, +1, +2, +3, and +4,respectively from left to right. In at least one example, the pluralityof zones can be numbered and color coded.

In any event, as illustrated in FIGS. 92-95, a pointer 9100 is movablebetween a plurality of positions to point to one of the nine zones. Anoperator of the surgical instrument 9010 may squeeze the firing trigger9094 while monitoring the position of the pointer 9100. Depending on theposition taken by the pointer 9100, the operator may reduce or increasethe pressure on the trigger 9094 until the pointer 9100 rests in themiddle or optimal zone. At such point, the operator may maintain thecurrent pressure on the firing trigger 9094 for the remainder of thefiring stroke. In certain instances, as illustrated in FIG. 96, thefeedback indicator 9066 may alert the operator that the firing stroke iscompleted.

In certain instances, as described above, the jaw members 9014, 9016include electrically conductive layers configured to deliver energy totissue captured between the jaw members 9014, 9016. An energy trigger oractuator can be moved or depressed between a plurality of positions orsettings, in a similar manner to the firing trigger 9094, to deliver theenergy to the tissue. The level or intensity of the energy delivered tothe tissue may depend on the selected position. For example, depressingthe energy trigger to a first position may yield a first energy level,and depressing the energy trigger to a second position, different fromthe first position, may yield a second energy level different from thefirst energy level. A tracking system, like the tracking system 9080,can track the position of the energy trigger and report such manualinput to the microcontroller 9061. Alternatively, the resulting energylevel can be monitored and reported to the microcontroller 9061. Acurrent sensor or a voltage sensor, for example, can be employed tomonitor the resulting energy level.

In any event, the microcontroller 9061 may be configured to characterizethe selected position of the energy trigger and/or the resulting energylevel in view of one or more measured parameters of the end effector9012 and/or one or more characteristics of the captured tissue such astissue thickness, tissue compression, and/or tissue impedance. One ormore sensors can be employed to obtain measurements of one or parametersof the end effector and/or one or more characteristics of the capturedtissue, which can be reported in real-time to the microcontroller 9061.In response, the microcontroller 9061 may characterize the selectedposition of the energy trigger and/or the resulting energy level byselecting or determining a position, rank, and/or status of the selectedposition of the energy trigger and/or the resulting energy level withrespect to a desired zone or range. As described above, the memory unit9068 can include an algorism, equation, and/or look-up table fordetermining the position, rank, and/or status of the selected positionof the energy trigger and/or the resulting energy level. Furthermore,the position, rank, and/or status can be reported to the operator of theenergy trigger in real-time via a feedback indicator, similar to thefeedback indicator 9066, for example.

One of the advantages of the feedback methods and systems of the presentdisclosure is that they reduce the number of variables that an operatorneed to consider while providing a manual input such as, for example,actuating the firing trigger 9094. As such, the operator is relievedfrom having to manually consider each of the measured parameters of theend effector 9012 to estimate the adequacy of a manual input and/or anoutput value resulting from the manual input such as the speed of thecutting member 9040. Instead, a current manual input and/or an outputvalue of the manual input can be automatically characterized by themicrocontroller 9061 in view of all the measured parameters of the endeffector 9012 to provide the operator with one consolidated real-timefeedback through the feedback indicator 9066. The operator may thenfocus on such feedback and adjust the manual input to achieve an optimalresult.

Further to the above, the feedback methods and systems of the presentdisclosure would give the operator a repeatable relative measure tojudge the adequacy of a manual input. In addition, the operator coulddecide for themselves how far beyond an optimal zone, with respect tosuch relative measure, they are willing to reach comfortably to achievea good outcome. Furthermore, the feedback methods and systems of thepresent disclosure would also give the operator a warning if the firingwas out of the ordinary so that additional caution may be exercised.Furthermore, by focusing on the one consolidated real-time feedback, anoperator can learn quicker the best way to fire a surgical instrument.

The present disclosure also provides novel techniques for modular reloadto identify itself and define a program of operation of a motorcontroller to actuate the module.

One technique includes defining a table of programs and configuring amodule to communicate to the handle which software programs (or othermachine executable instructions) to select and execute. By way ofcontrast, other techniques are contemplated that do not include nooperating programs in the handle portion of the endosurgical device andinstead store the program in the module itself and uploads the programat the time of attachment for the handle to execute. In anothertechnique, no programs would be executed in the handle. The handle wouldcontain the motor controller, the actuation buttons, and even the powercontroller, but not the operating programs. The module would contain allthe upper level logic and a sub-processor to execute the program suchthat each module includes a main processor and the program specific tothat reload. When the shaft is attached to the handle, the processorbecomes energized and it identifies the handle to which it is attached.Once identified the handle is slaved to the modular reload with themodule giving and processing all commands. When a button is depressed,for example, the module responds and determines the next action and thencommunicates to the slaved motor controller how far and how fast to moveand when to stop. With the inclusion of the master processor in themodule there also should be a relatively high bandwidth communicationbus between the module and the handle to enable the necessarycommunication traffic. This can be accomplished by holding the rotaryshaft component of the modular attachment within a station frameattachment component such that the stationary part houses the processorand control program. Therefore, the communication bus does not have toalso serve as a slip ring contact set.

As described herein, a surgical system can include modular components,which can be attached and/or combined together to form a surgicalinstrument. Such modular components can be configured to communicate andinteract to affect surgical functions. Referring again to the surgicalinstrument 10 (FIGS. 1-4), the surgical instrument 10 includes a firstmodular component 14 (FIG. 1), e.g., a handle assembly 14, and a secondmodular component 200 (FIG. 1), e.g., an attachment assembly thatincludes an elongate shaft 260 (FIG. 1) and an end effector 300 (FIG.1), which are described herein. The handle assembly 14 and theattachment assembly 200 can be assembled together to form the modularsurgical instrument 10 or at least a portion thereof. Optionally, adifferent modular component may be coupled to the handle assembly 14,such as an attachment having different dimensions and/or features thanthose of the attachment assembly 200 (FIG. 1), for example. For example,alternative attachments can be interchangeable with the attachmentassembly 200. In various instances, the surgical instrument 10 caninclude additional modular components, such as a modular battery 90(FIG. 4), for example.

The modular surgical instrument 10 (FIGS. 1-4) can include a controlsystem that is designed and configured to control various elementsand/or functions of the surgical instrument 10. For example, the handleassembly 14 (FIG. 1) and the attachment assembly 200 (FIG. 1) can eachcomprise a circuit board 100 (FIG. 4), 610 (FIG. 7), respectively,having at least one control system. The control systems of the modularcomponents 14, 200 can communicate and/or cooperate. In certaininstances, a table of control modules can be accessible to thecontroller in the handle assembly 14 of the surgical system 10. Thecontroller in the attachment assembly 200 can instruct the handleassembly 14 to select and implement at least one of the controlmodule(s) from the table. In such instances, the controller in thehandle assembly 14 can access and run the control module(s). In otherinstances, the controller in the attachment assembly 200 can include atleast one control module. The appropriate control module(s) can beuploaded to the controller in the handle assembly 14, which can run thecontrol module(s). In such instances, the controller in the handleassembly 14 can also access and run the control module(s). Additionallyor alternatively, various control module(s) in the handle assembly 14and/or the attachment assembly 200 can be updated. For example, thecontroller in the handle assembly 14 can be configured to downloadupdated and/or modified control module(s) from the controller in theattachment assembly 200. U.S. patent application Ser. No. 14/226,133,entitled MODULAR SURGICAL INSTRUMENT SYSTEM, filed Mar. 26, 2014, nowU.S. Patent Application Publication No. 2015/0272557, which describesvarious surgical systems and control systems thereof, is herebyincorporated by reference herein in its entirety.

In still other instances, a processor of the surgical instrument 10(FIGS. 1-4) can comprise a master processor, and another processor ofthe surgical instrument 10 can comprise a slave processor. An operatingsystem and/or a plurality of control modules can be accessible to themaster processor. The operating system and/or the control modules canaffect at least one surgical function with and/or by an element orsubsystem of the surgical instrument 10, for example. A control modulecan comprise software, firmware, a program, a module, and/or a routine,for example, and/or can include multiple software, firmware, programs,control modules, and/or routines, for example. The control modules canaffect a surgical function based on a pre-programmed routine, operatorinput, and/or system feedback, for example. In various instances, themaster processor can be configured to direct information and/or commandsto the slave processor. Moreover, the slave processor can be configuredto receive information and/or commands from the master processor. Theslave processor can act in response to the commands from the masterprocessor. In various instances, the slave processor may not include acontrol module(s) and/or operating system, and the actions of the slaveprocessor can be attributed to command(s) from the master processor andthe control module(s) accessible to the master processor. As describedherein, the control system in the attachment assembly 200 (FIG. 1) ofthe surgical instrument system 10 can include a master processor, andthe control system in the handle assembly 14 (FIG. 1) of the surgicalinstrument system 10 can include at least one slave processor, forexample.

Referring again to the surgical instrument 10 (FIGS. 1-4), the handleassembly 14 can be compatible with different attachments, which can beconfigured to affect different surgical functions. The variousattachments can be interchangeable, and the different surgical functionscan correspond to different tissue types and/or different surgicalprocedures, for example. Because different attachments can be configuredto affect different surgical functions, control modules specific to theparticular attachments can be stored on the respective attachments. Forexample, the attachment assembly 200 (FIG. 1) can store the specificcontrol module(s) for operating the attachment assembly 200.Additionally, the attachment assembly 200 can include the upper levellogic and sub-processor to run the control module(s). In such instances,the processor in the attachment assembly 200 can comprise a mastercontrol system and/or master processor that is configured to command aslave processor in the handle assembly 14 to implement the controlmodule(s) stored on the attachment assembly 200.

Because each attachment includes the specific control module(s) for itsoperation and because the processor in the attachment comprises themaster processor, the modular surgical instrument 10 is configured torun the most appropriate and up-to-date control module(s) for theparticular attachment. Additionally, as updated and/or revisedattachments and/or control module(s) therefor and designed andimplemented, the updated and/or revised attachments are designed toproperly work with handle assemblies that have less recent updatesand/or revisions. In other words, updated and/or revised attachments canbe retrofit to operate properly with existing and/or out-of-date handleassemblies.

As described herein, the handle assembly 14 (FIG. 1) includes a firingdrive system 80 that includes a motor 82 (FIG. 4). The handle assembly14 also includes a battery 90 (FIG. 90), a handle circuit board 100(FIG. 4), and an electrical connector 1400 (FIG. 4). A motor controller,such as the motor controller 2043 (FIGS. 21A and 21B), for example,which is described herein, can be configured to control the operation ofthe motor 82. For example, the motor controller 2043 can initiaterotation of the motor 82 and/or can control the direction and/or speedof motor rotation.

As described herein, the attachment assembly 200 (FIG. 1) can include ashaft circuit board 610 and an electrical connector 1410 (FIG. 7). Theelectrical connector 1410 (FIG. 3) on the attachment assembly 200 can beconfigured to engage the electrical connector 1400 (FIG. 4) on thehandle assembly 14 (FIG. 1) to provide a conduit and/or conductivepathway for transferring power and/or information between the handleassembly 14 and the attachment assembly 200. The electrical connectors1400, 1410 can be mounted to stationary components of the surgicalinstrument 10 (FIGS. 1-4). Referring to FIG. 3, for example, theelectrical connection 1410 in the attachment assembly 200 is mounted tothe shaft chassis 244, which remains stationary relative to theintermediate firing shaft 222. Because the electrical connections 1400,1410 are stationary relative to each other, the connections 1400, 1410can provide a high bandwidth communication bus to enable traffic betweenthe connections 1400, 1410.

In various instances, when the attachment assembly 200 (FIG. 1) isattached to the handle assembly 14 (FIG. 1), the electrical connectors1400 (FIG. 3), 1410 (FIG. 3) can be engaged and the battery 90 (FIG. 4)in the handle assembly 14 can power the handle assembly 14 and theattachment assembly 200. For example, the battery 90 can provide powerto the shaft circuit board 610 (FIG. 7) when the attachment assembly 200is coupled to the handle assembly 14. In various instances, the battery90 can automatically power the shaft circuit board 610 and/or componentsthereof when the attachment assembly 200 is connected to the handleassembly 14.

Referring now to FIG. 97, a schematic depicting the various controlsystems for a modular surgical instrument system, such as the surgicalinstrument 10 (FIGS. 1-4), for example, is depicted. A first controlsystem 10000 can be positioned in a modular attachment, such as theattachment assembly 200 (FIG. 1), and a second control system 10014 canbe positioned in a modular handle, such as the handle assembly 14 (FIG.1). The attachment control system 10000 includes a master processor10012, which is configured to issue commands to a slave processor. Forexample, the handle control system 10014 includes a slave processor10018, which can be slaved to the master processor 10012 in the modularattachment 200. In various instances, the slave processor 10018 cancorrespond to a motor controller, such as the motor controller 2043(FIGS. 21A and 21B), for example. In such instances, the motorcontroller 2043 in the handle assembly 14 of the surgical instrument 10can be slaved to the master processor 10012 in the modular attachment200. For example, the master processor 10012 can issue commands to themotor controller 2043, which can affect actuation of the motor 82 (FIG.4), for example, and can control the direction and/or speed of motorrotation.

Referring still to FIG. 97, the control system 10000 in the modularattachment 200 can also include at least one sensor 10010, which can bein communication with the master processor 10012 in the modularattachment 200 (FIG. 1). Various exemplary sensors for detectingconditions within the shaft 260, within the end effector 300 (FIGS. 1and 2), and/or at the surgical site are described herein. In certaininstances, the master processor 10012 can select a control module and/orprogram to run based on feedback from the sensors 10010. For example,the thickness, density, and/or temperature of tissue detected by one ofthe sensors 10010 can be communicated to the master processor 10012 andthe operating module(s) and/or program selected by the master processor10012 can account for the detected condition(s) within the end effector300.

The handle control system 10014 depicted in FIG. 97 also includes adisplay processor 10016, which can be similar to the display segment2002 d of segmented circuit 2000 (FIGS. 21A and 21B), for example. Incertain instances, the display processor 10016 can be configured tocontrol the information provided to and presented by a display. Invarious examples, the display can be integrally formed on the handleassembly 14 (FIG. 1) of the surgical instrument system 10 (FIG. 1). Instill other instances, the display can be separate and/or remote fromthe handle assembly 14 and the attachment assembly 200 (FIG. 1). In atleast one instance, the display processor 10016 is a slave to the masterprocessor 10012 in the attachment assembly 200. For example, the masterprocessor 10012 can send commands to the display processor 10016 and thedisplay processor 10016 can implement the commands.

Referring still to FIG. 97, the control system 10014 in the handleassembly 14 (FIG. 1) can include a safety coprocessor 10020, which canbe similar to the safety processor 2004 (FIGS. 21A and 21B), forexample. In various instances, the safety coprocessor 10020 can be insignal communication with the master processor 10012 in the modularattachment 200 (FIG. 1). The master processor 10012 can issue commandsto the safety coprocessor 10020, which can be specific to the modularattachment and/or the surgical functions performed by the particularmodular attachment. For example, the master processor 10012 can initiatethe safety operations of the safety coprocessor 10020. In variousinstances, after the safety operations of the safety coprocessor 10020have been initiated, the safety coprocessor 10020 can run independentlyand can notify the master processor 10012 if a triggering event occurs.

The control system 10014 in the handle assembly 14 (FIG. 1) can becoupled to a battery 10022, which can be similar to the battery 90 (FIG.4) positioned in the handle assembly 14 and the battery 2008 (FIGS. 21Aand 21B) in the power segment 2002 h (FIGS. 21A and 21B) of thesegmented circuit 2000, which are described herein. The battery 10022can power the control system 10014 in the handle assembly 14. Moreover,when the attachment assembly 200 is connected to the handle assembly 14,the battery 10022 can power the master control system 10000 in theattachment assembly 200 (FIG. 1). For example, the battery 10022 canpower the master processor 10012 in the attachment assembly 200. Invarious instances, when the attachment assembly 200 is attached to thehandle assembly 14, the battery 10022 can automatically power the masterprocessor 10012. For example, current can flow to the master processor10012 via the electrical connector 1400 (FIGS. 3 and 4) in the handleassembly 14 and the electrical connector 1410 (FIG. 7) in the attachmentassembly 200.

In various instances, the master processor 10012 can include a pluralityof control modules, which are specific to the surgical functions and/orcomponents of the attachment assembly 200 (FIG. 1). The control modulescan be accessible to and/or integral with the master processor 10012. Invarious circumstances, the master processor 10012 can include multipletiers and/or levels of command and the control modules can be organizedinto multiple tiers. For example, the master processor 10012 can includea first tier of control modules, a second tier of control modules,and/or a third tier of control modules. Control modules of the firsttier can be configured to issue commands to the control modules of thesecond tier, for example, and the control modules of the second tier canbe configured to issue commands to the control modules of the thirdtier. In various instances, the master processor 10012 can include lessthan three tiers and/or more than three tiers, for example.

The control module(s) in the first tier can comprise high-levelsoftware, or a clinical algorithm. Such a clinical algorithm can controlthe high-level functions of the surgical instrument 10 (FIGS. 1-4), forexample. In certain instances, the control module(s) in the second tiercan comprise intermediate software, or framework module(s), which cancontrol the intermediate-level functions of the surgical instrument 10,for example. In certain instances, the clinical algorithm of the firsttier can issue abstract commands to the framework module(s) of thesecond tier to control the surgical instrument 10. Furthermore, thecontrol modules in the third tier can comprise firmware modules, forexample, which can be specific to a particular hardware component, orcomponents, of the surgical instrument 10. For example, the firmwaremodules can correspond to a particular cutting element, firing bar,trigger, sensor, and/or motor of the surgical instrument 10, and/or cancorrespond to a particular subsystem of the surgical instrument 10, forexample. In various instances, a framework module can issue commands toa firmware module to implement a surgical function with thecorresponding hardware component. Accordingly, the various controlmodules of the surgical system 10 can communicate and/or cooperateduring a surgical procedure.

The master processor 10012 can include and/or access the control modulesof various tiers, which can affect different surgical functions. Incertain instances, the motor controller 10018 may not include anycontrol modules, and control modules may not be accessible to the motorcontroller 10018. For example, the motor controller 10018 may notinclude an operating system, framework module, and/or firmware module.In such instances, the motor controller 10018 can be slaved to themaster processor 10012, and the motor controller 10018 can be configuredto implement the commands issued by the master processor 10012.

As described herein, the master control system 1000 in the attachmentassembly 200 can communicate with the control system 10014 in the handleassembly 14 (FIG. 1) to affect a surgical function. In use, referringprimarily now to FIG. 98, modular components of a surgical instrument,such as the handle assembly 14 and the attachment assembly 200 (FIG. 1),can be attached 11000. Thereafter, at least one function can beinitiated by a master processor, such as the master processor 10012(FIG. 97), for example, which can include the control module(s) and/oroperating program(s) specific to the attachment assembly 200 (FIG. 1)and the surgical function(s) to be performed by the attachment assembly200.

With reference primarily to both FIGS. 97 and 98, a battery, such as thebattery 10022 can power 11010 the master processor 10012. As describedherein, when the attachment assembly 200 (FIG. 1) is properly coupled tothe handle assembly 14 (FIG. 1), the battery 10022 in the handleassembly 14 can power the master processor 10012. The powered masterprocessor 10012 can identify 11016 at least one slave processor, such asthe slave processors 10016 and 10018, for example. After the masterprocessor 10012 identifies 11016 at least one of the slave processor(s)10016, 10018, the master processor 10012 can issue commands to the slaveprocessor(s) 10016, 10018. The commands can be based on a pre-programmedroutine found in a control module accessible to the master processor10012.

In various instances, the master processor 10012 can request informationfrom other systems and/or controllers in the surgical instrument 10(FIGS. 1-4). For example, the master processor 10012 can requestinformation from a slaved processor. In certain instances, the masterprocessor 10012 can request information from an input system, such as anactuation button and/or trigger on the handle assembly 14 (FIG. 1).Additionally or alternatively, the master processor 10012 can requestinformation from a sensor and/or feedback system. For example, themaster processor 10012 can communicate with at least one sensor 10010 toobtain information on at least one condition in the surgical instrument10 and/or surgical site. The master processor 10012 can receive 11012information and/or inputs.

The master processor 10012 can issue at least one command to at leastone slave processor 10016, 10018 at step 11018. In certain instances,the command(s) can be based on the control module(s) accessible to themaster processor 10012 and/or the feedback and/or input received at step11012. For example, the master processor 10012 can command the slavedmotor controller 10018 to operate the motor 82 (FIG. 4) in the handleassembly 14 at a particular power level, in a particular direction,and/or for a particular duration. The control sequence of the motor 82can be determined and provided by a control module in the attachmentassembly 200 (FIG. 1). As a result, the control sequence can correspondto the particular attachment assembly 200 and the surgical function tobe performed by that attachment assembly 200.

At step 11014, the slaved processors 10016 and/or 10018 can implementthe command(s) from the master processor 10012. In various instances,the master processor 10012 can request information from various slavedsystems during and/or throughout implementation of the control sequence.In certain instances, based on the updated information, the masterprocessor 10012 can issue a new and/revised command and/or commands.Additionally or alternatively, the master processor 10012 can issueadditional commands to the slaved processor(s) throughout the operationof the surgical instrument 10 (FIGS. 1-4).

The present disclosure provides additional techniques to overcomechallenges with conventional modular endosurgical devices. Two of thesetechniques, in the context of modular endocutters, include wire contactsto transmit power and receive signals from an end effector shaftconfigured to rotate, and the ability to upgrade the modular attachmentwith new tech and sensors while allowing the handle to readily acceptthe new tech.

The ability for the sensors in the end-effector to have the signalprocessing capability built into the sensor itself helps improve both ofthese issues. In one aspect, the sensor can be configured to supply thehandle with processed information rather than supplying the handle withraw data to minimize the impact of newer sensors and the number of wiresnecessary to run them. In one aspect, a series of smart sensors can beplaced in parallel along a single power line with the shaft of thedevice as the return path and using current draw “signal” the handle tostop, or start, or end etc. In accordance with this technique, thehandle does not need to know what the sensor actually is or how tointerpret the processed information being fed back to the controller.Likewise, the current draw can be monitored using a standard Morse Codelike encoding technique on the power line to enable the handle to knowwhat the issue is and which sensor identified the issue without anypairing or other couple communication requirement.

Medical devices may be modular devices that include several separatecomponents. For example, an endocutter such as endocutter 12010 as shownin FIG. 99 may include several large and small separate components. Theendocutter 12010 is similarly constructed and equipped as themotor-driven surgical cutting and fastening instrument 10 described inconnection with FIGS. 1-29. Accordingly, for conciseness and clarity thedetails of operation and construction will not be repeated here.Endocutter 12010 may include a handle component 12012, a shaft component12014, and an end-effector component 12016. Each of the handle, theshaft, and the end-effector may include smaller but separate componentssuch as sensors, transducers, motors, switches, controllers, processorsetc., which may be programmable and interoperable with one another. Inthis way, endocutter 12010 may be a modular medical device.

In general, modular devices may have several challenges to overcome. Forexample, modular endocutter 12010 may require multiple wire contactsconfigured to transmit power and receive signals. A power source, suchas a battery 90 (FIG. 4), may transfer power to one or more sensors,transducers, motors, switches, controllers, processors, or other modularcomponents of the endocutter through various wires and wire contacts.One or more of these modular components may receive signals from oneanother in order to perform various calculations, processes, or actionsto operate the endocutter. For example, a sensor in end-effector 12016may be powered from a battery in handle 12012 through a wire in shaft12014 and may send back signals or data to a microprocessor ormicrocontroller in handle 12012 through a different wire in shaft 12014.The shaft 12014 may be only a half inch in diameter and may have theability to rotate, which may lead to challenges when swapping orupgrading modular components such as sensors.

In some systems, a sensor in the end-effector may send data to thehandle. The data may require signal processing or other processing byone or more components in the handle in order to be used to operate theendocutter. Adding a new sensor or upgrading an existing sensor mayrequire new wires to enable communication with the one or morecomponents (e.g., a microprocessor) in the handle. Having to add newwires or wire contacts may negatively impact the ability to use newsensors or upgrade existing sensors and may be undesirable. The abilityto upgrade the modular components (e.g., sensors) in, for example, theend-effector 12016, with new technology such as more advanced sensors,while allowing components in the handle 12012 (e.g., a microcontroller12024) to readily accept output from the new sensors without adding newwires or new wire contacts may be desirable.

In one aspect of the present disclosure, one or more sensors in theend-effector (e.g., end-effector 12016) may have local or built-insignal processing capability. These sensors may be referred to as smartsensors. Rather than supplying the handle or one or more componentstherein with data that may require further processing, smart sensorswith local signal processing may supply the handle with alreadyprocessed data or information that can be used to operate the endocutterwhile minimizing or eliminating further processing.

For example, the end-effector 12016 may include a sensor 12020 andsignal processing component 12022. The signal processing component 12022may correspond to the sensor 12020 (i.e., may be configured to processdata from sensor 12020). In one example, the signal processing component12022 may be specially designed or configured to process signals or datareceived from the sensor 12020. Further, the signal processing component12022 may generate processed information based on the signals or datareceived from sensor 12020. In this way, the signal processing component12022 may process data received from the sensor 12020 of a surgicalinstrument (i.e., the endocutter 12010) locally to the sensor and intoinformation usable by the surgical instrument.

The handle 12012 (or a component therein) may be configured to receivethe processed information from the signal processing component 12022.For example, the signal processing component 12022 may transmit theprocessed information to handle 12012 via shaft 12014 (through, e.g.,one or more wires). In this way, the processed information may betransmitted from the signal processing component 12022 to a controller12024 (e.g., a microcontroller) of the surgical instrument (e.g., theendocutter 12010). Further, the surgical instrument (e.g., theendocutter 12010) may be controlled based on the processed informationfrom the signal processing component 12022. For example, theend-effector 12016 may be stopped or started or a process of theendocutter 12010 may be ended based on the processed information. In oneexample, the controller 12024 may stop or start the end-effector basedon the processed information.

The signal processing component 12022 and the sensor 12020 may be partof a single module 12018. The single module 12018 may be positioned inthe end-effector 12016 and may be a modular component easily swappedinto or out of the end-effector 12016. The sensor 12020 may be, forexample, a magnetic field sensor, a magnetic sensor, an inductivesensor, a capacitive sensor, or another type of sensor used in medicaldevices or endocutters. The signal processing component 12022 may be themicrocontroller 2006 (FIGS. 21A, 21B) or microcontroller 3017 (FIGS.28A, 28B).

In one aspect, the signal processing component may be a sensor circuit12036 as shown in FIG. 100. The sensor circuit 12036 may be any suitablecircuit configured to read signals from a sensor component such as aninductive coil 12032. The sensor circuit 12036 may be in communicationwith or be communicatively coupled to a sensor component in theend-effector 12030. For example, the sensor circuit 12036 may becommunicatively coupled to an inductive coil 12032 via a wire or cable12038. The inductive coil 12032 may produce a magnetic field 12034 andmay be located at a distal end of an anvil 12040 of the end-effector12030. The sensor circuit 12036 may receive data or signals from thesensor component (e.g., inductive coil 12032) and may process the dataor signals to generate processed information which may be used tooperate the end-effector 12030.

While the sensor circuit 12036 is shown outside of the end-effector12030 and the anvil 12040 in FIG. 100 for ease of disclosure, the sensorcircuit 12036 may be local to the sensor component (e.g., inductive coil12032) or may be part of a single module including the sensor componentand the sensor circuit, such as single module 12018 of FIG. 99. Forexample, as shown in FIG. 101, a sensor circuit 12052 also may bepositioned at a distal end of an anvil 12056 of an end-effector 12050.The sensor circuit 12052 may be local to, and in communication with, asensing component such as magnet 12054.

Referring back to FIG. 99, the handle 12012 may include a controller12024 which may be configured to control or otherwise operate theendocutter 12010. In one example, the controller 12012 may be amicrocontroller and may be configured to receive the processedinformation from the signal processing component 12022 or the singlemodule 12018. For example the shaft 12014 may be configured tocommunicatively couple the signal processing component 12022 of theend-effector 12016 and the handle 12012. The microcontroller 12024 inthe handle 12012 may be in wired communication with the signalprocessing component 12022 via shaft 12014. In one example, the signalprocessing component 12022 may be in wireless communication with themicrocontroller 12024 or with another component in handle 12012. Whilethe controller 12024 may be configured to receive the processedinformation from the signal processing component 12022 or the singlemodule 12018, this is not intended to be a limitation of the presentdisclosure as various other components (e.g., a microprocessor, display,interface, switch, etc.) in handle 12012 may be configured to receivethe processed information from the signal processing component 12022 orthe single module 12018.

In one aspect, a plurality of smart sensors may be positioned on a powerline of an end-effector and may be communicatively coupled to a handleof an endocutter. The smart sensors may be positioned in series orparallel with respect to the power line. Referring now to FIG. 14, smartsensors 12060 and 12062 may be in communication with a signal processingcomponent or a microprocessor 12064 which may be local to the smartsensors. Both the smart sensors 12060 and 12062 and the microprocessor12064 may be located at the end-effector (represented by dashed-box12066). For example, smart sensor 12060 may output signals or data to anoperational amplifier 12068 and an ADC converter 12070, which maycondition the signals or data for input into microprocessor 12064.Similarly, smart sensor 12062 may output signals or data to anoperational amplifier 12072 and an ADC converter 12074, which maycondition the signals or data for input into microprocessor 12064.

Smart sensors 12060 and/or 12062 may be different types of sensors orthe same type of sensor, which may be, for example, magnetic fieldsensors, magnetic sensors, inductive sensors, capacitive sensors, orother types of sensors used in medical devices or endocutters. Component12064, previously referred to as a microprocessor, also may be acomputational core, FPGA (field programmable gate array), logic unit(e.g., logic processor or logic controller), signal processing unit, orother type of processor. The microprocessor 12064 may be incommunication with a memory, such as non-volatile memory 12076, whichmay store calculation data, equipment information such as a type ofcartridge inserted in the end-effector 12066, tabular data, or otherreference data that may enable the microprocessor 12064 to processsignals or data received from one or more of the smart sensors 12060 or12062 for use in operating the end-effector 12066 or an endocutter.

Further, a shaft 12078 may include a return path through which at leastone of the plurality of smart sensors (e.g., smart sensors 12060 or12062) and the handle 12080 are communicatively coupled. The shaft mayinclude one or more wires which may transfer information from themicroprocessor 12064 to the handle 12080 for operation of theend-effector 12066 or endocutter. In one example, the information fromthe microprocessor 12064 may be communicated to the handle 12080 (by wayof shaft 12078 or directly without use of shaft 12078) over one or moreof: a wired-line, a single-wired line, a multi-wired line, a wirelesscommunication protocol such as Bluetooth, an optical line, or anacoustic line.

In one aspect, at least one of a plurality of smart sensors positionedat an end-effector may include a signal processing component. Forexample, the signal processing component may be built into the smartsensor or may be locally coupled to the smart sensor as shown in singlemodule 12018 of FIG. 99. The signal processing component may beconfigured to process data received from a sensor component (e.g.,sensor component 12020) of at least one of the plurality of smartsensors. A controller 12024 (e.g., a microcontroller) at the handle maybe communicatively coupled to at least one of the plurality of smartsensors.

In one aspect, a smart sensor may be configured for local signalprocessing in a medical device. The smart sensor may include at leastone sensor component (e.g., sensor component 12020) and at least oneprocessing component (e.g., processing component 12022). The processingcomponent may be configured to receive data from the at least one sensorcomponent and to process the data into information for use by themedical device. The medical device may be, for example, an endocutter,however this is not intended to be a limitation of the presentdisclosure. It should be understood that the techniques and featuresdiscussed herein for smart sensors with local signal processing may beused in any medical device where processing of sensor signals or data isused for operation of the medical device.

Further, a controller (e.g., controller 12024, microcontroller) in themedical device may be configured to receive the information (i.e.,processed signals or data) from the at least one processing component(e.g., processing component 12022). As discussed above, the medicaldevice may be a surgical instrument such as an endocutter and the smartsensor may be configured for local signal processing in the surgicalinstrument. Local signal processing may refer to, for example,processing signals or data from a sensor component at a processingcomponent coupled to the sensor, where the resulting processedinformation may be used by a separate component. For example, thecontroller 12024 may be positioned in the handle 12012 of the surgicalinstrument (i.e., the endocutter 12010) and the smart sensor may beconfigured to be positioned in a separate component (i.e., theend-effector 12016) of the surgical instrument (i.e., the endocutter12010), separate from the handle 12012. Thus, the controller 12024 maybe positioned at the handle 12012 of the surgical instrument and thesignal processing component 12022 and the sensor 12020 may be located ina component separate from the handle 12012 (e.g., end-effector 12016).

In this way, the handle or controller 12024 need not have informationabout the smart sensor, knowledge of what the smart sensor is doing, orcapability to interpret data feed back from the smart sensor. This isbecause the processing component 12022 may transform or condition thedata from the smart sensor and generate information from the datadirectly usable by the handle or controller 12024. The informationgenerated by the processing component may be used directly, without thedata from the smart sensor needing to be processed in another part ofthe medical device (e.g., near the handle 12012 or controller 12024).Thus, the surgical instrument may be controlled based on the (processed)information from the signal processing component local to the sensor.

In one aspect, a current draw on a power line communicatively coupled tothe signal processing component 12022 (i.e., local to the sensor 12020)may be monitored. The current draw may be monitored by a microprocessoror other monitoring device at the shaft 12014 or the handle 12012, or atanother microprocessor or other monitoring device separate from thesignal processing component 12022. For example, the monitoring may be astandard Morse Code type monitoring of the current draw on the powerline. An issue with the surgical instrument based on the current drawand a particular sensor may be determined by the separate microprocessorat, e.g., the handle 12012. In this way, the monitoring may allow thehandle (or a processor or controller therein) to be informed of variousissues related to signals or data received by one or more sensor andwhich particular sensor identified the issue, without a furthercommunication requirement (e.g., pairing, or other coupledcommunication).

Turning now to FIG. 103, which is a logic diagram illustrating oneaspect of a process 13040 for calibrating a first sensor 13008 a inresponse to an input from a second sensor 13008 b. The first sensor13008 a is configured to capture 13022 a a signal indicative of one ormore parameters of the end effector 13000. The first signal 13022 a maybe conditioned based on one or more predetermined parameters, such as,for example, a smoothing function, a look-up table, and/or any othersuitable conditioning parameters. A second signal is captured 13022 b bythe second sensor 13008 b. The second signal 13022 b may be conditionedbased on one or more predetermined conditioning parameters. The firstsignal 13022 a and the second signal 13022 b are provided to aprocessor, such as, for example, the primary processor 2006 (FIGS.21A-21B). The primary processor 2006 calibrates 13042 the first signal13022 a in response to the second signal 13022 b. The first signal 13022a is calibrated 13042 to reflect the fullness of the bite of tissue inthe end effector 13000. The calibrated signal is displayed 13026 to anoperator by, for example, a display 12026 embedded in the surgicalinstrument 10 (FIGS. 1-6).

FIG. 104 is a logic diagram illustrating one aspect of a process 13170for adjusting a measurement of a first sensor 13158 in response to aplurality of secondary sensors 13160 a, 13160. In one example, a Halleffect voltage is obtained 13172, for example, by a magnetic fieldsensor. The Hall effect voltage is converted 13174 by an analog todigital convertor. The converted Hall effect voltage signal iscalibrated 13176. The calibrated curve represents the thickness of atissue section located between the anvil 13152 and the staple cartridge13156. A plurality of secondary measurements is obtained 13178 a, 13178b by a plurality of secondary sensors, such as, for example, a pluralityof strain gauges. The input of the strain gauges is converted 13180 a,13180 b into one or more digital signals, for example, by a plurality ofelectronic μStrain conversion circuits. The calibrated Hall effectvoltage and the plurality of secondary measurements are provided to aprocessor, such as, for example, the primary processor 2006 (FIGS.21A-21B). The primary processor utilizes the secondary measurements toadjust 13182 the Hall effect voltage, for example, by applying analgorithm and/or utilizing one or more look-up tables. The adjusted Halleffect voltage represents the true thickness and fullness of the bite oftissue clamped by the anvil 13152 and the staple cartridge 13156. Theadjusted thickness is displayed 13026 to an operator by, for example, adisplay 12026 embedded in the surgical instrument 10 (FIGS. 1-6).

FIG. 105 illustrates one aspect of a circuit 13190 configured to convertsignals from the first sensor 13158 and the plurality of secondarysensors 13160 a, 13160 b into digital signals receivable by a processor,such as, for example, the primary processor 2006 (FIGS. 21A-21B). Thecircuit 13190 comprises an analog-to-digital convertor 13194. In someexamples, the analog-to-digital convertor 13194 comprises a 4-channel,18-bit analog to digital convertor. Those skilled in the art willrecognize that the analog-to-digital convertor 13194 may comprise anysuitable number of channels and/or bits to convert one or more inputsfrom analog to digital signals. The circuit 13190 comprises one or morelevel shifting resistors 13196 configured to receive an input from thefirst sensor 13158, such as, for example, a magnetic field sensor. Thelevel shifting resistors 13196 adjust the input from the first sensor,shifting the value to a higher or lower voltage depending on the input.The level shifting resistors 13196 provide the level-shifted input fromthe first sensor 13158 to the analog-to-digital convertor.

In some aspects, a plurality of secondary sensors 13160 a, 13160 b arecoupled to a plurality of bridges 13192 a, 13192 b within the circuit13190. The plurality of bridges 13192 a, 13192 b may provide filteringof the input from the plurality of secondary sensors 13160 a, 13160 b.After filtering the input signals, the plurality of bridges 13192 a,13192 b provide the inputs from the plurality of secondary sensors 13160a, 13160 b to the analog-to-digital convertor 13194. In some examples, aswitch 13198 coupled to one or more level shifting resistors may becoupled to the analog-to-digital convertor 13194. The switch 13198 isconfigured to calibrate one or more of the input signals, such as, forexample, an input from a magnetic field sensor. The switch 13198 may beengaged to provide one or more level shifting signals to adjust theinput of one or more of the sensors, such as, for example, to calibratethe input of a magnetic field sensor. In some examples, the adjustmentis not necessary, and the switch 13198 is left in the open position todecouple the level shifting resistors. The switch 13198 is coupled tothe analog-to-digital convertor 13194. The analog-to-digital convertor13194 provides an output to one or more processors, such as, forexample, the primary processor 2006 (FIGS. 21A-21B). The primaryprocessor 2006 calculates one or more parameters of the end effector13150 based on the input from the analog-to-digital convertor 13194. Forexample, in one example, the primary processor 2006 calculates athickness of tissue located between the anvil 13152 and the staplecartridge 13156 based on input from one or more sensors 13158, 13160 a,13160 b.

FIG. 106 is a logic diagram illustrating one aspect of a process 13320for selecting the most reliable output from a plurality of redundantsensors, such as, for example, the plurality of sensors 13308 a, 13308b. In one example, a first signal is generated by a first sensor 13308a. The first signal is converted 13322 a by an analog-to-digitalconvertor. One or more additional signals are generated by one or moreredundant sensors 13308 b. The one or more additional signals areconverted 13322 b by an analog-to-digital convertor. The convertedsignals are provided to a processor, such as, for example, the primaryprocessor 2006 (FIGS. 21A-21B). The primary processor 2006 evaluates13324 the redundant inputs to determine the most reliable output. Themost reliable output may be selected based on one or more parameters,such as, for example, algorithms, look-up tables, input from additionalsensors, and/or instrument conditions. After selecting the most reliableoutput, the processor may adjust the output based on one or moreadditional sensors to reflect, for example, the true thickness and biteof a tissue section located between the anvil 13302 and the staplecartridge 13306. The adjusted most reliable output is displayed 13026 toan operator by, for example, a display 2026 embedded in the surgicalinstrument 10 (FIGS. 1-6).

FIG. 107 illustrates one aspect of an end effector 13000 comprising amagnet 13008 and a magnetic field sensor 13010 in communication with aprocessor 13012. The end effector 13000 is similar to the end effector300 (FIG. 1) described above in connection with surgical instrument 10(FIGS. 1-6). The end effector 13000 comprises a first jaw member, oranvil 13002, pivotally coupled to a second jaw member, or elongatedchannel 13004. The elongated channel 13004 is configured to operablysupport a staple cartridge 13006 therein. The staple cartridge 13006 issimilar to the staple cartridge 304 (FIG. 1) described above inconnection with surgical instrument 10 (FIGS. 1-6). The anvil 13008comprises a magnet 13008. The staple cartridge comprises a magneticfield sensor 13010 and a processor 13012. The magnetic field sensor13010 is operable to communicate with the processor 13012 through aconductive coupling 13014. The magnetic field sensor 13010 is positionedwithin the staple cartridge 13006 to operatively couple with the magnet13008 when the anvil 13002 is in a closed position. The magnetic fieldsensor 13010 can be configured to detect changes in the magnetic fieldsurrounding the magnetic field sensor 13010 caused by the movement of orlocation of magnet 13008.

FIGS. 108-110 illustrate one aspect of an end effector that comprises amagnet where FIG. 108 illustrates a perspective cutaway view of theanvil 13102 and the magnet 13058 a, in an optional location. FIG. 109illustrates a side cutaway view of the anvil 13102 and the magnet 13058a, in an optional location. FIG. 110 illustrates a top cutaway view ofthe anvil 13102 and the magnet 13058 a, in an optional location.

FIG. 111 illustrates one aspect of an end effector 13200 that isoperable to use conductive surfaces at the distal contact point tocreate an electrical connection. The end effector 13200 is similar tothe end effector 300 (FIG. 1) described above in connection withsurgical instrument 10 (FIGS. 1-6). The end effector 13200 comprises ananvil 13202, an elongated channel 13204, and a staple cartridge 13206.The anvil 13202 further comprises a magnet 13208 and an inside surface13210, which further comprises a number of staple-forming indents 13212.In some examples, the inside surface 13210 of the anvil 13202 furthercomprises a first conductive surface 13214 surrounding thestaple-forming indents 13212. The first conductive surface 13214 cancome into contact with second conductive surfaces 13222 on the staplecartridge 13206. The cartridge body comprises a number of staplecavities designed to hold staples (not pictured). In some examples thestaple cavities further comprise staple cavity extensions that protrudeabove the surface of the cartridge body. The staple cavity extensionscan be coated with the second conductive surfaces. Because the staplecavity extensions protrude above the surface of the cartridge body, thesecond conductive surfaces will come into contact with the firstconductive surfaces 13214 when the anvil 13202 is in a closed position.In this manner the anvil 13202 can form an electrical contact with thestaple cartridge 13206.

FIG. 112 illustrates one aspect of a staple cartridge 13606 thatcomprises a flex cable 13630 connected to a magnetic field sensor 13610and processor 13612. The staple cartridge 13606 is similar to the staplecartridge 13606 is similar to the staple cartridge 306 (FIG. 1)described above in connection with surgical instrument 10 (FIGS. 1-6).FIG. 112 is an exploded view of the staple cartridge 13606. The staplecartridge comprises 13606 a cartridge body 13620, a wedge sled 13618, acartridge tray 13622, and a flex cable 13630. The flex cable 13630further comprises electrical contacts 13632 at the proximal end of thestaple cartridge 13606, placed to make an electrical connection when thestaple cartridge 13606 is operatively coupled with an end effector, suchas end effector 13800 described below. The electrical contacts 13632 areintegrated with cable traces 13634, which extend along some of thelength of the staple cartridge 13606. The cable traces 13634 connect13636 near the distal end of the staple cartridge 13606 and thisconnection 13636 joins with a conductive coupling 13614. A magneticfield sensor 13610 and a processor 13612 are operatively coupled to theconductive coupling 13614 such that the magnetic field sensor 13610 andthe processor 13612 are able to communicate.

FIG. 113 illustrates one aspect of an end effector 13800 with a flexcable 13830 operable to provide power to a staple cartridge 13806 thatcomprises a distal sensor plug 13816. The end effector 13800 is similarto the end effector 300 (FIG. 1) described above in connection withsurgical instrument 10 (FIGS. 1-6). The end effector 13800 comprises afirst jaw member or anvil 13802, a second jaw member or elongatedchannel 13804, and a staple cartridge 13806 operatively coupled to theelongated channel 13804. The end effector 13800 is operatively coupledto a shaft assembly. The shaft assembly is similar to shaft assembly 200(FIG. 1) described above in connection with surgical instrument 10(FIGS. 1-6). The shaft assembly further comprises a closure tube thatencloses the exterior of the shaft assembly. In some examples the shaftassembly further comprises an articulation joint 13904, which includes adouble pivot closure sleeve assembly. The double pivot closure sleeveassembly includes an end effector closure sleeve assembly that isoperable to couple with the end effector 13800.

FIGS. 114 and 115 illustrate the elongated channel 13804 portion of theend effector 13800 without the anvil 13802 or the staple cartridge, toillustrate how the flex cable 13830 can be seated within the elongatedchannel 13804. In some examples, the elongated channel 13804 furthercomprises a third aperture 13824 for receiving the flex cable 13830.Within the body of the elongated channel 13804 the flex cable splits13834 to form extensions 13836 on either side of the elongated channel13804. FIG. 115 further illustrates that connectors 13838 can beoperatively coupled to the flex cable extensions 13836.

FIG. 116 illustrates the flex cable 13830 alone. As illustrated, theflex cable 13830 comprises a single coil 13832 operative to wrap aroundthe articulation joint 13904 (FIG. 113), and a split 13834 that attachesto extensions 13836. The extensions can be coupled to connectors 13838that have on their distal facing surfaces prongs 13840 for coupling tothe staple cartridge 13806, as described below.

FIG. 117 illustrates a close up view of the elongated channel 13804shown in FIGS. 114 and 115 with a staple cartridge 13804 coupledthereto. The staple cartridge 13804 comprises a cartridge body 13822 anda cartridge tray 13820. In some examples the staple cartridge 13806further comprises electrical traces 13828 that are coupled to proximalcontacts 13856 at the proximal end of the staple cartridge 13806. Theproximal contacts 13856 can be positioned to form a conductiveconnection with the prongs 13840 of the connectors 13838 that arecoupled to the flex cable extensions 13836. Thus, when the staplecartridge 13806 is operatively coupled with the elongated channel 13804,the flex cable 13830, through the connectors 13838 and the connectorprongs 13840, can provide power to the staple cartridge 13806.

FIGS. 118 and 119 illustrate one aspect of a distal sensor plug 13816.FIG. 118 illustrates a cutaway view of the distal sensor plug 13816. Asillustrated, the distal sensor plug 13816 comprises a magnetic fieldsensor 13810 and a processor 13812. The distal sensor plug 13816 furthercomprises a flex board 13814. As further illustrated in FIG. 119, themagnetic field sensor 13810 and the processor 13812 are operativelycoupled to the flex board 13814 such that they are capable ofcommunicating.

FIG. 120 illustrates one aspect of an end effector 13950 with a flexcable 13980 operable to provide power to sensors and electronics in thedistal tip 13952 of the anvil 13961 portion. The end effector 13950comprises a first jaw member or anvil 13961, a second jaw member orelongated channel 13954, and a staple cartridge 13956 operativelycoupled to the elongated channel. The end effector 13950 is operativelycoupled to a shaft assembly 13960. The shaft assembly 13960 furthercomprises a closure tube 13962 that encloses the shaft assembly 13960.In some examples the shaft assembly 13960 further comprises anarticulation joint 13964, which includes a double pivot closure sleeveassembly 13966.

In various aspects, the end effector 13950 further comprises a flexcable 13980 that is configured to not interfere with the function of thearticulation joint 13964. In some examples, the closure tube 13962comprises a first aperture 13968 through which the flex cable 13980 canextend. In some examples, flex cable 13980 further comprises a loop orcoil 13982 that wraps around the articulation joint 13964 such that theflex cable 13980 does not interfere with the operation of thearticulation joint 13964, as further described below. In some examples,the flex cable 13980 extends along the length of the anvil 13961 to asecond aperture 13970 in the distal tip of the anvil 13961.

FIGS. 121-123 illustrate the operation of the articulation joint 13964and flex cable 13980 of the end effector 13950. FIG. 121 illustrates atop view of the end effector 13952 with the end effector 13950 pivoted−45 degrees with respect to the shaft assembly 13960. As illustrated,the coil 13982 of the flex cable 13980 flexes with the articulationjoint 13964 such that the flex cable 13980 does not interfere with theoperation of the articulation joint 13964. FIG. 122 illustrates a topview of the end effector 13950. As illustrated, the coil 13982 wrapsaround the articulation joint 13964 once. FIG. 123 illustrates a topview of the end effector 13950 with the end effector 13950 pivoted +45degrees with respect to the shaft assembly 13960. As illustrated, thecoil 13982 of the flex cable 13980 flexes with the articulation joint13964 such that the flex cable 13980 does not interfere with theoperation of the articulation joint 13964.

FIG. 124 illustrates cross-sectional view of the distal tip of oneaspect of an anvil 13961 with sensors and electronics 13972. The anvil13961 comprises a flex cable 13980, as described with respect to FIGS.121-123. As illustrated in FIG. 124, the anvil 13961 further comprises asecond aperture 13970 through which the flex cable 13980 can pass suchthat the flex cable 13980 can enter a housing 13974 in the within theanvil 13961. Within the housing 13974 the flex cable 13980 can operablycouple to sensors and electronics 13972 located within the housing 13974and thereby provide power to the sensors and electronics 13972.

FIG. 125 illustrates a cutaway view of the distal tip of the anvil13961. FIG. 125 illustrates one aspect of the housing 13974 that cancontain sensors and electronics 13972 as illustrated by FIG. 124.

A surgical instrument can be powered by a battery. In at least oneembodiment, the handle of the surgical instrument comprises a batterycavity and the battery can be inserted into and removed from the batterycavity. In certain embodiments, the surgical instrument can comprise ashaft assembly which includes a battery cavity and a battery removablypositioned in the battery cavity. When the battery is seated in thebattery cavity, the battery can supply power to the handle. The batteryand/or the handle, for example, can comprise a releasable lock whichreleasably holds the battery in the battery cavity. In variousinstances, the releasable lock comprises a latch which can be depressedby the user of the surgical instrument to unlock the battery and permitthe battery to be removed from the battery cavity. In various instances,the battery can be removed from the handle and replaced with anotherbattery. U.S. Patent Application Publication No. 2012/0071711, entitledSURGICAL INSTRUMENTS AND BATTERIES FOR SURGICAL INSTRUMENTS, which wasfiled on Sep. 17, 2010, now U.S. Pat. No. 9,289,212, and U.S. Pat. No.8,632,525, entitled POWER CONTROL ARRANGEMENTS FOR SURGICAL INSTRUMENTSAND BATTERIES, which was filed on Sep. 17, 2010, are incorporated byreference herein in their respective entireties.

Referring now to FIGS. 126-128, a surgical instrument 14000 comprises ahandle 14010 including a housing 14011 and a battery cavity 14012defined in the housing 14011. The surgical instrument 14000 furthercomprises an end effector configured to deploy staples from a staplecartridge; however, the surgical instrument 14000 can comprise anysuitable end effector. The handle 14010 further comprises a firingmember 14050 which is movable proximally and distally to articulate theend effector of the surgical instrument 14000 about an articulationjoint. The firing member 14050 is also movable distally to fire staplesfrom the staple cartridge and retractable proximally after the stapleshave been fired. FIGS. 126-128 depict the firing member 14050 in anunfired position. The firing member 14050 is movable proximally anddistally by an electric motor and/or a hand crank, for example, and istranslatable within a proximally-extending chamber 14016. The chamber14016 comprises a proximal end 14013 which encloses the firing member14050 and extends proximally into the battery cavity 14012. The chamber14016 is sized and configured to provide a clearance gap 14055 for thefiring member 14050 which, in at least one instance, permits the firingmember 14050 to be retracted proximally from its unfired position inorder to articulate the end effector. In other instances, as discussedin greater detail further below, the chamber 14016 comprises an openproximal end.

The surgical instrument 14000 further comprises a battery 14020 which ispositionable in the battery cavity 14012 to supply power to the handle14010. The battery 14020 comprises a battery housing 14021 having anouter surface 14022. The battery cavity 14012 and the outer surface14022 of the battery 14020 are configured such that the battery 14020 isclosely received in the battery cavity 14012. In at least one instance,the battery cavity 14012 and the outer surface 14022 are configured suchthat the battery 14020 can be inserted into the battery cavity 14012 inonly one orientation, or in a limited number of orientations. Thebattery 14020 comprises a clearance aperture 14026 defined thereinconfigured to receive the chamber 14016 when the battery 14020 ispositioned in the battery cavity 14012. The handle 14010 furthercomprises one or more electrical contacts 14014 (FIG. 131) which areengaged by corresponding electrical contacts 14024 (FIG. 131) defined onthe battery 14020 when the battery 14020 is fully seated in the batterycavity 14012. Moreover, a proximal end 14025 of the battery 14020 isflush, or at least substantially flush, with the handle housing 14011when the battery 14020 is fully seated in the battery cavity 14012. Whenthe battery 14020 is not fully seated in the battery cavity 14012, thebattery contacts 14024 may not be engaged with the handle contacts 14014and, in such a position, the battery 14020 cannot supply power to thehandle 14010.

In various embodiments, the battery 14020 is the only power sourceavailable to the handle 14010. In other embodiments, more than one powersource is available to the handle 14010. In at least one suchembodiment, the battery 14020 is the primary power source for the handle14010. Regardless of the embodiment utilized, the battery 14020 canprovide a large portion of, if not all of, the power needed by thehandle 14010. In the event that the battery 14020 were to bedisconnected from the handle 14010 and/or removed from the batterycavity 14012 during a surgical procedure, the handle 14010 would becomeunpowered and/or underpowered. In some instances, removing the battery14020 from the battery cavity 14012 may be preferred or required toreplace a depleted battery 14020 with a fully-charged battery 14020, forinstance. In other instances, removing the battery 14020 from thebattery cavity 14012 during a critical point of the surgical proceduremay not be preferred, such as when the firing member 14050 is beingadvanced distally to fire the staples from the staple cartridge, forexample. In at least one such instance, a sudden loss of power mayrender a control circuit 14015 and/or display screen 14040 of the handle14010 inoperable, for example. In light of the above, the handle 14010includes a battery lock, or means which can prevent the battery 14020from becoming electrically de-coupled from the handle 14010 and/orremoved from the battery cavity 14012 at certain points during theoperation of the handle 14010. There are other reasons for locking thebattery 14020 in the handle 14010. For instance, the battery 14020 canbe locked to the handle 14010 so that the handle 14010 and/or battery14020 can be disposed of safely.

Referring again to FIGS. 126-128, the handle 14010 comprises one or moredeployable locks 14017. Each lock 14017 is movable between anundeployed, or unlocked, position (FIG. 127) and a deployed, or locked,position (FIGS. 126 and 128). Each lock 14017 comprises a cantileverbeam extending from a sidewall of the chamber 14016; however, anysuitable configuration could be utilized. Each lock 14017 comprises aproximal end mounted to a sidewall of the chamber 14016 and a distal endwhich is movable relative to the proximal end. The proximal end of eachlock 14017 can be pivotably attached to a sidewall of the chamber 14016.The locks 14017, and/or the sidewalls of the chamber 14016, can becomprised of a resilient material and can be configured to deflect whena biasing force is applied thereto. Each lock 14017 comprises a camsurface 14018 defined on the distal end thereof.

The handle 14010 further includes a lock actuator 14030 configured tomove the locks 14017 between their undeployed position (FIG. 127) totheir deployed position (FIG. 128). The lock actuator 14030 comprises asolenoid; however, the lock actuator 14030 could comprise any suitableactuator, such as an electric motor, for example. The lock actuator14030 comprises a wire coil 14034 mounted in the handle housing 14011and, in addition, an armature 14032 movable relative to the wire coil14034. The armature 14032 comprises an elongate aperture 14031 definedtherein which is sized and configured to permit the firing member 14050to slide therein. In various instances, a clearance gap can be presentbetween the firing member 14050 and the armature 14032.

The armature 14032 is comprised of a ferrous material, for example, andthe wire coil 14034 is comprised of a conductive wire, such as copperwire, for example. When electrical current flows through the wire coil14034 in a first direction, the field generated by the flowing currentpushes the armature 14032 from a first, or distal, position (FIG. 127)to a second, or proximal, position (FIG. 128). The armature 14032comprises a proximal end 14038 configured to engage the cam surfaces14018 of the locks 14017 when the armature 14032 is moved proximally anddeflect the locks 14017 outwardly, as illustrated in FIG. 128. Whenelectrical current flows through the wire coil 14034 in a second, oropposite, direction, the field generated by the flowing current pushesthe armature 14032 from its second, or proximal, position (FIG. 128) toits first, or distal, position (FIG. 127). When the armature 14032 ismoved distally, the proximal end 14038 of the armature 14032 isdisengaged from the cam surfaces 14018 of the locks 14017 and the locks14017 can then resiliently deflect inwardly back to their undeployedpositions. The locks 14017 can comprise any suitable configuration and,in at least one instance, the locks 14017 are integrally-molded with thechamber 14016 and can be attached to the chamber 14016 in a living-hingearrangement, for example. In other instances, the locks 14017 cancomprise separate components which are mounted to the chamber 14016, forexample.

Further to the above, each lock 14017 comprises a lock shoulder 14019which is displaced outwardly when the locks 14017 are displacedoutwardly, as described above. When the locks 14017 are moved into theirdeployed positions, as illustrated in FIG. 128, the lock shoulders 14019of the locks 14017 are moved behind lock shoulders 14029 defined in thebattery housing 14021. When the lock shoulders 14019 are positionedbehind the lock shoulders 14029 of the battery 14020 by the lockactuator 14030, the battery 14020 cannot be disengaged from the handle14010. As a result, the battery contacts 14024 remain engaged with thehandle contacts 14014 and the power supplied to the handle 14010 by thebattery 14020 may not be interrupted. In the event that the user of thesurgical instrument 14000 pulls on the battery 14020 when the batterylock 14030 has been actuated, the lock shoulders 14029 of the battery14020 can abut the lock shoulders 14019 of the lock arms 14017.Moreover, the armature 14032 can buttress and support the lock arms14017 in their deployed positions such that battery contacts 14024 donot break contact with the handle contacts 14014. It is envisioned thatsome relative movement between the battery 14020 and the handle 14010may occur even though the battery lock 14030 has been actuated; however,such movement is insufficient to electrically decouple the battery 14020from the handle 14010.

The armature 14032 comprises a stop 14033 defined on the distal endthereof which is configured to limit the proximal travel of the armature14032. In at least one embodiment, the stop 14033 is configured tocontact the wire coil 14034, as illustrated in FIG. 128. In variousinstances, the wire coil 14034 can remain energized to hold the armature14032 in its proximal, or locked, position (FIG. 128). In certaininstances, the armature 14032 can be held in place by friction forcesbetween the armature 14032 and the walls of the chamber 14026, forexample, even though the wire coil 14034 is not being energized. Similarto the above, the handle 14010 can include a distal stop configured tolimit the distal movement of the armature 14032. As mentioned above, thewire coil 14034 of the lock actuator 14030 can be energized to activelymove the armature 14032 proximally and distally; however, the lockactuator 14030 can include a biasing member, such as a spring, forexample, which can be configured to bias the armature 14032 in eitherthe proximal direction or the distal direction. For instance, in atleast one embodiment, the wire coil 14034 is energized to move thearmature 14032 proximally and a return spring is configured to move thearmature 14032 distally after the wire coil 14034 is no longerenergized. Alternatively, in at least one embodiment, the wire coil14034 is energized to move the armature 14032 distally and a returnspring is configured to move the armature 14032 proximally after thewire coil 14034 is no longer energized.

As discussed above, the lock actuator 14030 can be selectively actuatedto deploy the locks 14017 and de-actuated to retract the locks 14017.The lock actuator 14030 is in signal communication with the controlcircuit 14015 which can control the actuation of the lock actuator14030. The control circuit 14015 can include a microprocessor which candetermine when to activate and de-activate the lock actuator 14030. Themicroprocessor can be configured to evaluate one or more operatingparameters of the surgical instrument 14000 to determine whether toactivate or de-activate the lock actuator 14030. For instance, themicroprocessor can be configured to evaluate the voltage and/or currentof the battery 14020 to determine whether the battery 14020 issufficiently charged to operate the handle 14010 and, if the battery14020 has a sufficient charge, activate the lock actuator 14030 todeploy the locks 14017, or, if the battery 14020 does not have asufficient charge, de-activate the lock actuator 14030 to permit thebattery 14020 to be removed from the handle 14010.

Alternatively, the control circuit 14015 can utilize the lock actuator14030 to prevent the battery 14020 from being removed from the handle14010 in the event that the control circuit 14015 determines that thehandle 14010 has exceeded its useful life. The control circuit 14015 candetermine that the handle 14010 has exceeded its useful life if thefiring system of the handle 14010 has been operated a certain number oftimes and/or if the handle 14010 has been sterilized a certain number oftimes, for example. In certain instances, the lock actuator 14030 canprevent the battery 14020 from being moved relative to the handle 14010.In at least one such instance, the control circuit 14015 of the handle14010 can utilize the display screen 14040 to indicate to the user thatthe battery 14020 has been locked in position and that the handle 14010should be either disposed of or serviced. In certain instances, thebattery 14020 can include indicia thereon and the lock actuator 14030can be configured to permit the battery 14020 to be translated a limiteddistance to expose the indicia when a clinician pulls on the battery14020. The indicia can be on the side of the battery housing 14021 andcan visible above the handle housing 14011 after the battery 14020 hasbeen displaced. The indicia can have a contrasting color to otherportions of the battery housing 14021, for example, and/or writteninstructions to the user of the surgical instrument 14000 such as theword “dispose” and/or “service”, for example. In certain instances, thebattery housing 14021 can include detention features which can engagethe handle housing 14011 and hold the battery 14020 in its displacedposition.

In certain embodiments, further to the above, a battery housing cancomprise a two-part housing—a first portion which includes the batterycells 14023 and the electrical contacts 14024 and a second portion whichis separable from the first portion, for example. In ordinary use, thefirst portion and the second portion of the battery housing areconnected together and are unmovable relative to one another. The firstportion can include a gripping portion, such as the proximal end 14025,for example, which allows the user of the surgical instrument 14000 tograb the battery housing and remove both portions of the battery housingsimultaneously. If the control circuit 14015 has determined that thehandle 14010 has reached its end of life, the control circuit 14015 canactuate a lock actuator which engages and holds the second portion ofthe battery housing. When the user of the surgical instrument 14000attempts to remove the battery 14020 from the battery cavity 14012 ofthe handle 14010 after the lock actuator has been actuated, the firstportion of the battery housing can separate from the second portionthereby leaving the second portion behind in the battery cavity 14012.As a result of the second portion being locked within and unremovablefrom the battery cavity 14012, a new battery 14020 is not positionablein the battery cavity 14012. In various instances, the first portionand/or the second portion of such a battery housing can include indiciathereon explaining to the user of the surgical instrument 14000 that thehandle 14010 is no longer usable. Such indicia may only be visible afterthe first housing portion has separated from the second housing portion.In certain instances, the first housing portion and the second housingportion can be connected by a ribbon which is exposed, or unfurled, whenthe first housing portion detaches from the second housing portion. Theribbon can include instructions thereon for handling, disposing, and/orrefurbishing the handle 14010. When the handle 14010 is refurbished, thelock actuator can be reset and the second housing portion can be removedfrom the battery cavity 14012.

Further to the above, the handle and/or the battery can comprise anexposable portion which can be exposed by the control system when thecontrol system determines that the handle and/or the battery is nolonger suitable for use. The exposable portion can be displaced and/orotherwise exposed by an actuator operated by the control system. Theexposable portion can include indicia, such as words and/or acontrasting color, for example, which only become visible when thecontrol system has deactivated the handle and/or the battery in at leastone way.

In various embodiments, the handle 14010 can include an override buttonin communication with the microprocessor which, when actuated, caninstruct the microprocessor to deactivate the lock actuator and permitthe battery to be removed. Other embodiments may not include such anoverride button.

In various instances, a surgical instrument may become unsuitable foruse in a surgical procedure. A handle of a surgical instrument canbecome unsuitable for use when the handle has exceeded its intendednumber of uses, for example. A handle of a surgical instrument may alsobecome unsuitable for use when it experiences excessive force loadingand/or electrical faults, for example. Moreover, a handle of a surgicalinstrument may become unsuitable for use when another component of thesurgical instrument is incorrectly attached to the handle and/or anincorrect component is attached to the handle. When the control systemof the handle determines that the handle may be unsuitable for use, thecontrol system may employ a battery lockout which can prevent a batteryfrom being operably coupled to the handle, as described in greaterdetail further below.

A handle 14110 is depicted in FIGS. 129 and 130. The handle 14110 issimilar to the handle 14010 in many respects. The handle 14110 comprisesa handle housing 14111 which includes a battery cavity 14012 configuredto receive a battery 14020, as described above. The handle housing 14111further comprises a chamber 14116 configured to receive the firingmember 14050 which, similar to the chamber 14016, extends into thebattery cavity 14012. The handle 14110 further comprises one or moredeployable lockout arms 14117. Each lockout 14117 is movable between anundeployed position (FIG. 129) and a deployed position (FIG. 130). Eachlockout 14117 comprises a cantilever beam extending from a sidewall ofthe chamber 14116; however, any suitable configuration could beutilized. Each lockout 14117 comprises a distal end mounted to asidewall of the chamber 14116 and a proximal end which is movablerelative to the distal end. The distal end of each lockout 14117 can bepivotably attached to a sidewall of the chamber 14116. The lockouts14117, and/or the sidewalls of the chamber 14116, can be comprised of aresilient material and can be configured to deflect when a biasing forceis applied thereto. Each lockout 14117 comprises a cam surface 14118defined on the proximal end thereof.

The handle 14110 further includes a lock actuator 14030 configured tomove the lockouts 14117 from their undeployed position (FIG. 129) totheir deployed position (FIG. 130). The lock actuator 14030 comprises asolenoid; however, the lock actuator 14030 could comprise any suitableactuator, such as a motor, for example. The lock actuator 14030comprises a wire coil 14034 mounted in the handle housing 14111 and, inaddition, an armature 14032 movable relative to the wire coil 14034. Thearmature 14032 comprises an elongate aperture 14031 defined thereinwhich is sized and configured to permit the firing member 14050 to slidetherein. In various instances, a clearance gap can be present betweenthe firing member 14050 and the armature 14032.

The armature 14032 is comprised of a ferrous material, for example, andthe wire coil 14034 is comprised of a conductive wire, such as copperwire, for example. When electrical current flows through the wire coil14034 in a first direction, the field generated by the flowing currentpushes the armature 14032 from a first, or distal, position (FIG. 129)to a second, or proximal, position (FIG. 130). The armature 14032comprises a proximal end 14038 configured to engage the cam surfaces14118 of the lockouts 14117 when the armature 14032 is moved proximallyand deflect the lockouts 14117 outwardly, as illustrated in FIG. 130.When electrical current flows through the wire coil 14034 in a second,or opposite, direction, the field generated by the flowing currentpushes the armature 14032 from its second, or proximal, position (FIG.130) to its first, or distal, position (FIG. 129). When the armature14032 is moved distally, the proximal end 14038 of the armature 14032 isdisengaged from the cam surfaces 14118 of the lockouts 14117 and thelockouts 14117 can then resiliently deflect inwardly back to theirundeployed positions.

Further to the above, each lockout 14117 comprises a lock shoulder 14119which is displaced outwardly when the lockouts 14117 are displacedoutwardly, as described above. When the lockouts 14117 are moved intotheir deployed positions, as illustrated in FIG. 130, the lock shoulders14119 of the lockouts 14117 are moved in front of lock shoulders 14028defined in the battery housing 14021. When the lock shoulders 14119 arepositioned in front of the lock shoulders 14028 of the battery 14020 bythe lock actuator 14030, the battery 14020 cannot be fully seated in thehandle 14110. As a result, the battery contacts 14024 cannot engage thehandle contacts 14014 and the battery 14020 cannot supply power to thehandle 14110. In the event that the user of the handle 14100 pushes onthe battery 14020 when the battery lockout 14130 has been actuated, thearmature 14032 can buttress and support the lockouts 14117 in theirdeployed positions.

A handle 14210 is depicted in FIG. 131. The handle 14210 is similar tothe handle 14010 and/or the handle 14110 in many respects. The handle14210 comprises a handle housing 14211 including a battery cavity 14012configured to receive a battery 14020. The handle housing 14211 furthercomprises a chamber 14216 configured to receive the firing member 14050which, similar to the chamber 14016 and the chamber 14116, extends intothe battery cavity 14012. The chamber 14216 of the handle 14210,however, comprises an open proximal end 14213. As illustrated in FIG.131, the open proximal end 14213 is sized and configured to permit thefiring member 14050 to extend therethrough. When the control system ofthe handle 14210 has determined that the handle 14210 is not suitablefor use, further to the above, the control system can operate theelectric motor which advances and retracts the firing member 14050 toposition the firing member 14050 in a lockout position, i.e., a positionin which the firing member 14050 prevents the electrical contacts 14024of the battery 14020 from engaging the electrical contacts 14014 of thehandle 14210. As illustrated in FIG. 131, the firing member 14050 can beretracted to a position in which the proximal end 14025 of the battery14020, for example, contacts the firing member 14050 before the battery14020 is sufficiently seated enough in the battery cavity 14012 tosupply power to the handle 14210.

In at least one alternative embodiment, a handle of a surgicalinstrument system can include a battery cavity and at least one firstelectrical contact and at least one second electrical contact positionedin the battery cavity which are in communication with the control systemof the handle. When the battery is fully seated in the battery cavity,the battery is electrically coupled with the first electrical contactand can fully power the handle. Similar to the above, the handle caninclude a battery lockout system which can be activated to prevent thebattery from being fully seated in the battery cavity. Moreover, thebattery lockout system can prevent the battery from being electricallycoupled with the first electrical contact when the battery lockoutsystem is activated. In contrast to the battery lockout systemsdescribed above, however, the battery lockout system of the currentembodiment can permit the battery to be electrically coupled with thesecond electrical contact even though the battery lockout has beenactivated. In such instances, the control system of the handle canutilize the power supplied to the second electrical contact by thebattery to operate the handle in a limited function mode.

In a limited function mode, further to the above, the control system mayonly be able to perform diagnostic functions to assess the condition ofthe handle and/or communicate the condition of the handle to the user.In at least one limited function mode, the control system may not beable to operate the electric motor to advance the firing member 14050distally but it may be able to operate the electric motor to retract thefiring member 14050 proximally, for example. The control system may alsooperate the display and/or permit the control buttons which interfacewith the display to be operated when the handle is being operated in alimited function mode, for example.

In at least one embodiment, further to the above, the first handlecontact can be positioned deeper in the battery cavity than the secondhandle contact. In at least one such instance, the battery can include abattery contact which can engage the first handle contact or the secondhandle contact, depending on the depth in which the battery is insertedinto the battery cavity. In at least one instance, the battery cancomprise a first battery contact configured to engage the first handlecontact when the battery is inserted to a first depth and a secondbattery contact configured to engage the second handle contact when thebattery is inserted to a second depth which is different than the firstdepth.

In certain embodiments, further to the above, the firing member 14050can be pushed proximally into the battery cavity 14012 to displace thebattery 14020 proximally and electrically decouple the battery 14020from the handle 14210. In such instances, the firing member 14050 candisplace the battery 14020 proximally such that the battery contacts14024 are no longer engaged with the handle contacts 14014. The controlsystem of the handle can decouple the battery 14020 from the handle whenthe control system has determined that the handle is no longer suitablefor use. In certain other embodiments, further to the above, the firingmember 14050 can push a battery from a first position in which thebattery is electrically coupled to a first electrical contact to asecond position in which the battery is electrically decoupled from thefirst electrical contact and electrically coupled to a second electricalcontact. Similar to the above, the control system of the handle may onlyuse the power supplied to the second electrical contact to perform alimited number of functions. In such instances, the control system canswitch itself between a fully-functional operating mode and alimited-function operating mode. In various instances, the handlehousing can include a catch feature which can prevent the battery frombeing electrically decoupled from the second electrical contact and/orpushed entirely out of the battery cavity in the handle housing.

As discussed herein, the firing member 14050 can enter into a batterycavity to prevent a battery from being fully installed into a handleand/or contact a battery to at least partially displace the battery outof the battery cavity. In various other instances, the firing member14050 itself may not block a battery cavity and/or push a batteryproximally; rather, the proximal movement of the firing member 14050 outof its ordinary range of motion can trip a spring-loaded mechanism whichcan block a battery cavity and/or push a battery proximally, forexample. In at least one instance, the spring-loaded mechanism caninclude at least one pre-stretched and/or at least one pre-compressedspring member that is released when tripped by the firing member 14050,for example. Such a spring-loaded mechanism can also deploy anindicator, for example, when it is tripped which can indicate to theuser that the handle has entered into a different operating mode. Incertain embodiments, the control system of a handle may actuate aspring-loaded mechanism directly without using the firing member 14050to trip the spring-loaded mechanism. While a spring could be utilized tostore energy and deliver that energy to a cocked actuator to perform thefunctions discussed herein, any suitable device capable of storing andreleasing energy could be utilized. In various instances, the device canbe pre-energized or pre-loaded when the handle is supplied to the user.

In addition to or in lieu of the above, the control system of a handlecan move the firing member 14050, either proximally or distally, to aninoperative position to render the handle unusable if the control systemdetects a defect in the handle and/or otherwise determines that thehandle should not be used. In at least one instance, the firing member14050 can be moved, either proximally or distally, to a position inwhich the electric motor becomes mechanically decoupled from the firingmember 16050 and the electric motor can no longer move the firing member14050 proximally or distally, for example. In another instance, thefiring member 14050 can be moved, either proximally or distally, to aposition in which the firing member 14050 impedes the operability ofanother system of the handle, such as a closing system used to close anend effector of the surgical instrument. In certain instances, thefiring member 14050 can be moved, either proximally or distally, to aposition in which a modular shaft assembly cannot be operably coupled tothe handle and/or the firing member 14050. In some instances, the firingmember 14050 can be moved, either proximally or distally, to a positionin which a modular shaft assembly cannot be operably de-coupled from thehandle and/or the firing member 14050. In view of the above, the firingmember 14050 of a handle can be moved out of a typical operating rangeof positions to render the handle inoperable in at least one capacity.

Further to the above, the firing member 14050 is movable within a firingoperating range to fire staples from a staple cartridge and/or anarticulation operating range to articulate the end effector of thesurgical instrument. In certain embodiments, the firing member 14050 ismovable within a clamping operating range to close an end effectorand/or clamp tissue within the end effector. The firing operating range,the articulation operating range, and/or the clamping operating rangecan comprise the typical operating range of positions discussed above.As also discussed above, the firing member 14050 can be moved out ofthis typical operating range to change the operating state of the handlein some manner. In at least one embodiment, the firing member 14050 canbe moved proximally out of its typical operating range to cycle or indexa use counter after every time that the handle has been used. The usecounter can be cycled mechanically and/or electronically. The usecounter can be in communication with the processor of the handle whichcan utilize data from the use counter to determine whether the handle isstill suitable for use. The control system of the handle, including thehandle microprocessor, the use counter, and/or one or more sensorsconfigured to monitor the electric motor which drives the firing member14050, for example, can be part of a diagnostic system which determineswhether the handle is suitable for use.

The exemplary embodiments illustrated in FIGS. 126-131 depict two lockarms or two lockout arms, as the case may be; however, one lock arm, orlockout arm, could be used. Moreover, more than two lock arms, orlockout arms, could be used. The lock arms, or lockout arms, of theexemplary embodiments are deployed simultaneously; however, otherembodiments are envisioned in which they are deployed sequentially.Furthermore, the embodiment of FIGS. 126-128, which comprises a batterylock system, could be combined with the embodiment of FIGS. 129 and 130and/or the embodiment of FIG. 131, which comprise battery lockoutsystems. In various embodiments, a single system can perform the batterylock and battery lockout functions described herein.

As discussed above, a surgical instrument can include a handle, a shaftassembly, and an end effector. The handle can include an electric motorhaving a rotatable output shaft which is operably coupled to a driveshaft in the shaft assembly. The output shaft can rotate the drive shaftor, alternatively, the rotary motion of the output shaft can beconverted to translational motion before being transmitted to the driveshaft. In either event, a property of the output shaft can be measuredwhile it is driving the drive shaft. Various embodiments can include oneor more sensors, for example, positioned relative to the output shaftwhich can measure the motion of the drive shaft, for example. Suchsensors are positioned off-board with respect to the shaft. Suchembodiments can be useful; however, the off-board positioning of thesensors can limit the properties of the drive shaft which can bedetected and/or the manner in which the properties of the drive shaftare detected. Various embodiments are discussed below which comprise oneor more sensors which are positioned on the output shaft which candetect a property of the drive shaft. Such sensors are positionedon-board with respect to the shaft. Also discussed below are embodimentswhich can include a control circuit mounted to the shaft and/or meansfor transmitting power to the control circuit.

Referring now to FIGS. 132 and 133, a surgical instrument system 15000comprises an electric motor 15010 including a rotatable shaft 15020. Theelectric motor 15010 can comprise any suitable electric motor, such as adirect current (DC) electric motor, for example. The electric motor15010 is mounted in a handle of a surgical instrument; however, theelectric motor 15010 can be mounted in any suitable portion of asurgical instrument, such as the shaft assembly extending from thehandle, for example. In certain other embodiments, the electric motor15010 can be part of a robotically-controlled assembly. In any event,the motor shaft 15020 is rotatably supported by any suitable number ofbearings such that the shaft 15020 is rotatable by the electric motor15010 about a longitudinal axis 15021.

Referring primarily to FIG. 132, the surgical instrument system 15000further comprises a drive system 15030 operably coupled with the motorshaft 15020. The drive system 15030 is positioned in the handle of thesurgical instrument; however, the drive system 15030 may be positionedin any suitable portion of the surgical instrument, such as the shaftassembly extending from the handle, for example. In certain otherembodiments, the drive system 15030 can be part of arobotically-controlled assembly. In any event, the drive system 15030comprises a transmission 15031 and an output shaft 15032. Thetransmission 15031 is configured to transmit rotary motion between themotor shaft 15020 to the output shaft 15032. The transmission 15031comprises a plurality of intermeshed gears, for example. In variousinstances, the gears of the transmission 15031 are configured such thatthe rotational velocity of the output shaft 15032 is different than therotational velocity of the motor shaft 15020. In at least one suchinstance, the rotational velocity of the output shaft 15032 is less thanthe rotational velocity of the motor shaft 15020. In various alternativeembodiments, the gears of the transmission 15031 are configured suchthat the rotational velocity of the output shaft 15032 is the same asthe rotational velocity of the motor shaft 15020.

Referring again to FIGS. 132 and 133, the surgical instrument system15000 further comprises a sensor 15050 mounted to the output shaft15020. The sensor 15050 comprises a strain gauge; however, any suitablesensor could be utilized. For instance, the sensor 15050 could comprisean accelerometer, for example. The strain gauge 15050 is mounted to theoutside surface 15023 of the output shaft 15020. The strain gauge 15050comprises a substrate, or backing, 15052 comprised of an insulativematerial which is flexible and conformable to the outside surface 15023of the shaft 15020. The backing 15052 is attachable to the outsidesurface 15023 of the shaft 15020 by any suitable adhesive, such ascyanoacrylate, for example. The strain gauge 15050 further comprises ametallic wire 15053 mounted to the substrate 15052. When the shaft 15020experiences a load and is elastically and/or plastically deformed by theload, the metallic wire 15053 is also deformed by the load and, as aresult, the electrical resistance of the metallic wire 15053 changes.This change in resistance, usually measured using a Wheatstone bridge,is related to the strain, or deformation, being experienced by the shaft15020 by a ratio known as a gauge factor.

When an electrical conductor, such as the metallic wire 15053, forexample, is stretched within the limits of its elasticity such that itdoes not break or permanently deform, the electrical conductor willbecome narrower and longer which increases its electrical resistancefrom end-to-end. Conversely, when the electrical conductor is compressedsuch that it does not buckle, it will broaden and shorten whichdecreases its electrical resistance from end-to-end. The electricalconductor of a resistive strain gauge often comprises a long, thinconductive strip arranged in a continuous zig-zag pattern of parallellines. These parallel lines of the conductive strip are usually spacedclose together such that a large length of the conductive strip ispositioned over a small area. Owing to the large length of theconductive strip, a small amount of stress in the direction of theorientation of the parallel lines results in a multiplicatively largerstrain measurement over the effective length of the conductor—and hencea multiplicatively larger change in resistance—than would be observedwith a single straight-line conductive wire. From the measuredelectrical resistance of the strain gauge 15050, the amount of stressbeing applied to the motor shaft 15020 may be inferred.

The surgical instrument system 15000 further comprises a control system15040 which is positioned on the motor shaft 15020. The control system15040 includes a circuit board 15046 mounted to the motor shaft 15020.The circuit board 15046 can be comprised of a printed circuit boardand/or a flexible laminate, for example, and can be attached to theoutside surface 15023 of the shaft 15020 utilizing one or moreadhesives, for example. The control system 15040 can include a controlcircuit on the circuit board 15046. The control circuit comprises, amongother things, a microprocessor 15047 and at least one memory chip 15048in signal communication with the microprocessor 15047. The strain gauge15050 is also in signal communication with the microprocessor 15047which is configured to detect the resistance change in the metallic wire15053 of the strain gauge 15050, as discussed above. When the shaft15020 is rotated to operate the end effector articulation system, thetissue-clamping system, and/or the staple-firing system of a surgicalinstrument, for example, the shaft 15020 will experience forces and/ortorques T that create strain within the shaft 15020 which is detected bythe strain gauge 15050 and the microprocessor 15047, as discussed ingreater detail further below. The microprocessor 15047 can include theWheatstone bridge discussed above.

The strain gauge 15050, further to the above, can comprise any suitablestrain gauge. For instance, the strain gauge 15050 can comprise asemiconductor strain gauge, a piezoresistor, a nano-particle basedstrain gauge, a fiber optic strain gauge, and/or a capacitive straingauge, for example. Certain strain gauges are configured to measurestrain along one axis while other strain gauges are configured tomeasure strain along more than one axis, such as two axes or three axes,for example. More than one strain gauge can be used to assess the strainof the shaft 5020. For example, a first strain gauge can be used toassess the strain of the shaft 5020 along a first axis and a secondstrain gauge can be used to assess the strain of the shaft 5020 along asecond axis. In at least one such instance, a first strain gauge can bepositioned and arranged to measure the strain along the longitudinalaxis 5021 of the shaft 5020 and a second strain gauge can be positionedand arranged to measure the strain around the circumference of the shaft5020. The strain measured along the circumferential axis of the shaft5020 is orthogonal to the strain measured along the longitudinal axis;however, other embodiments are envisioned in which the first axis andthe second axis are transverse, but not orthogonal to one another. Invarious instances, one or more strain gauges can be utilized to evaluatethe total, or overall, strain being experienced by the shaft 15020 at aparticular location on the shaft 15020. In certain instances, aplurality of strain gauges can be utilized to evaluate the strain of theshaft 15020 at a plurality of locations on the shaft 15020.

The strain gauge 15050 can be utilized to evaluate the strain, and thestress, being experienced by the shaft 15020. When the shaft 15020 isbeing utilized to drive an articulation system, a large increase instrain can indicate that the end effector of the surgical instrument maynot be articulating properly. Similarly, a large increase in strain canindicate that the firing member of the surgical instrument may havebecome stuck when the shaft 15020 is being utilized to drive a firingsystem. The microprocessor 15047, and/or any other microprocessor of thesurgical instrument, can be programmed to interpret the strain data andutilize the strain data to interpret whether the operation of thesurgical instrument should be modified. For example, a strain readingsupplied by the strain gauge 15050 to the microprocessor 15047 when theshaft 15020 is being utilized to articulate an end effector may exceed amaximum articulation strain threshold and, in such instances, themicroprocessor 15047, for example, can be programmed to interrupt theoperation of the motor 15010 driving the shaft 15020 when the strainreading exceeds the maximum articulation strain threshold. The samestrain reading, if provided when the shaft 15020 is being utilized tofire staples from the end effector, may or may not exceed a maximumfiring strain threshold. If the strain reading does not exceed themaximum firing strain threshold, then the microprocessor 15047 may notinterrupt the operation of the electric motor 15010. If the strainreading exceeds the maximum firing strain threshold, then themicroprocessor 15047 may interrupt the operation of the motor 15010. Incertain instances, the maximum firing strain threshold is different thanthe maximum articulation strain threshold while, in other instances,they may be the same.

In some instances, further to the above, interrupting the motor 15010may mean that the microprocessor 15047, and/or any other microprocessorof the surgical instrument, immediately pauses the motor 15010 untilreceiving an input from the user of the surgical instrument. Such aninput can be a command to reverse the operation of the motor 15010 or acommand to override the interruption of the motor 15010 and restart themotor 15010 to complete the articulation or firing process, as the casemay be. In certain instances, interrupting the motor 15010 may meanslowing the motor 15010 down which can give the microprocessor 15047,for example, a longer period of time to evaluate the loading conditionsbeing experienced by the shaft 15020. If the increase in strainrepresents a transient, or temporary, increase and the measured straindrops back below the relevant threshold, the microprocessor 15047 maynot interrupt the motor 15010. If the microprocessor 15047 has slowedthe motor 15010 in response to an elevated strain reading, themicroprocessor 15047 may restore the original speed of the motor 15010after the strain drops back below the relevant threshold. In otherinstances, the microprocessor 15047 may continue to operate the motor15010 at the slower speed even though the strain has dropped back belowthe relevant threshold. If, however, the elevated strain reading abovethe relevant threshold persists, the microprocessor 15047 can operatethe motor 15010 at the slower speed and/or pause the motor 15010 after apredetermined period of time has elapsed. In the event that the measuredstrain continues to increase over the threshold, the microprocessor15047 can be programmed to stop the motor 15010.

As discussed above, the microprocessor 15047 is positioned on the shaft5020. In order for the microprocessor 15047 to control the motor 15010driving the shaft 15020, the microprocessor 15047 needs to be able tocommunicate with the motor 15010. In at least one instance, a slip ringsystem can be utilized to transmit one or more signals from themicroprocessor 15047 to the motor 15010. The slip ring system can alsobe utilized to transmit and/or one or more signals from the motor 15010,and/or sensors monitoring the motor 15010, to the microprocessor 15047.In certain instances, a transmitter 15060 can be utilized to transmitdata between the microprocessor 15047 and the motor 15010. Thetransmitter 15060 is mounted to the shaft 15020 and rotates with theshaft 15020. The transmitter 15060 is in signal communication with themicroprocessor 15047 and, in at least one instance, can comprise awireless frequency emitter configured to generate a wireless signalutilizing data provided by the microprocessor 15047. The frequencyemitter can be in communication with the microprocessor 15047 via one ormore power wires and/or one or more signal wires which are mounted tothe shaft 15020. Alternatively, as described in greater detail furtherbelow, the transmitter 15060 can comprise an impedance field generator.

When the transmitter 15060 comprises a wireless frequency emitter, thesurgical instrument can comprise a wireless frequency receiver 15070configured to receive the signal emitted by the frequency emitter. Thefrequency receiver 15070 is positioned in the handle of the surgicalinstrument; however, the frequency receiver 15070 can be positioned inany suitable location in the surgical instrument. In various instances,the frequency receiver 15070 is in signal communication with the motor15010 such that the data transmitted within the wireless signal andreceived by the frequency receiver 15070 can directly control the motor15010. In other instances, the frequency receiver 15070 is in signalcommunication with a second microprocessor 15080 in the surgicalinstrument. The second microprocessor 15080 is positioned in the handleof the surgical instrument; however, the second microprocessor 15080 canbe positioned in any suitable location in the surgical instrument. Thesecond microprocessor 15080 can utilize the data transmitted from themicroprocessor 15047, and/or any other data from one or more suitableinputs, to control the motor 15010. The second microprocessor 15080 isin signal communication with the motor 15010 via one or more signaland/or power wires 15082, for example. The second microprocessor 15080can also be programmed to control the motor 15010 in the mannerdescribed above. In various instances, the microprocessors 15047 and15080 can co-operate to control the motor 15010.

The control system 15040, the sensor 15050, and the transmitter 15060comprise an on-board detection system configured to detect and evaluateone or more conditions of the shaft 15020. In the embodiment describedabove, the condition of the shaft 15020 is the operating load beingexperienced by the shaft 15020 and the sensor 15050 comprises a straingauge configured to detect the operating load; however, any suitablecondition of the shaft 15020 can be detected by one or more on-boardsensors positioned on the shaft 15020. Moreover, the microprocessor15047 can be configured to arrange the data provided to themicroprocessor 15047 from a plurality of sensors into two or moresignals and the wireless frequency emitter can be configured to emitthose signals to the frequency receiver 15070. Such signals can then beprovided to the microprocessor 15080 which can control the motor 15010in response to the signals that it has received. One or more signalmultiplexers and demultiplexers could be utilized.

While a wireless frequency emitter can be useful to communicate databetween a rotating plane, i.e., the shaft 15020, and a fixed plane,i.e., the handle of the surgical instrument, for example, thetransmitter 15060 can be configured to communicate data in any suitablemanner. In at least one embodiment, as mentioned above, the transmitter15060 can comprise an impedance field generator. In at least oneinstance, the impedance field generator can comprise an impedance coilmounted to the outside surface 15023 of the shaft 15020. The impedancefield generator can be configured to generate a field which can besensed by a field sensor 15070 positioned in the handle, for example.Similar to the above, the impedance field generator moves within arotating plane and the field sensor is positioned within a fixed plane.

Further to the above, the magnitude of the field generated by theimpedance field generator corresponds to the magnitude of the straindetected by the strain gauge 15050. For instance, higher emitted fieldintensities can be associated with larger strains while lower emittedfield intensities can be associated with smaller strains. In at leastone instance, the magnitude of the field emitted by the impedance fieldgenerator can be directly proportional to the magnitude of the straindetected by the strain gauge 15050. In such an embodiment, the fieldsensor can measure the intensity of the field created by the impedancefield generator and communicate such information to the microprocessor15080, for example. The microprocessor 15080 can comprise a calibrationtable which relates the data received from the field sensor to the loadbeing experienced by the motor shaft 15020. The microprocessor 15080 canalso be configured to adjust the speed of the electric motor 15010 inresponse to the data received from the strain gauge 15050 and theimpedance field generator. For instance, the microprocessor 15080 canslow the electric motor 15010 when the measured strain is high. Themicroprocessor 15080 can also utilize any other suitable data to adjustthe performance characteristics of the electric motor 15010. Such datacould include the current draw of the motor 15010, the impedance of thetissue being stapled, the tissue gap between the anvil and the staplecartridge, and/or the strain that the anvil is experiencing, forexample.

The impedance field generator described above transmits data between amoving shaft 15020 and the handle without the use of electricalcontacts. As a result, it can be said that the impedance field generatorcommunicates data from the shaft 15020 to the handle ‘wirelessly’;however, it can also be stated that the impedance field generator isbeing used to affect a measurement that is being made adjacent to themoving shaft 15020 which is then turned into a data stream andinterpreted.

As the reader will appreciate, the control system 15040, the sensor15050, and the transmitter 15060 may require electrical power tooperate. In at least one instance, one or more batteries can be mountedto shaft 15020 which can supply power to the control system 15040, thesensor 15050, and/or the transmitter 15060, for example. In addition toor in lieu of a battery, power can be supplied to the control system15040, the sensor 15050, and/or the transmitter 15060, for example, viaa slip ring system, such as the one described above, for example. Inaddition to or in lieu of the above, power can be transmitted wirelesslyto the control system 15040, the sensor 15050, and/or the transmitter15060, for example. In at least one such instance, the surgicalinstrument can include a magnet 15041 configured to generate a magneticfield 15042 which induces a current in a wire coil 15043 wound aroundthe shaft 15020 when the shaft 15020 is rotated by the electric motor15010. The wire coil 15043 is in electrical communication with thecontrol system 15040 such that the current induced within the wire coil15043 can supply power to the microprocessor 15047, the strain gaugesensor 15050, and/or the transmitter 15060, for example. In at least onesuch instance, the wire coil 15043 comprises a first end 15044 and asecond end 15045 mounted to contacts on the board 15046.

The magnet 15041 comprises a permanent magnet; however, the magnet 15041can comprise any suitable magnet, such as an electromagnet, for example.When the magnet 15041 comprises a permanent magnet, the magnet 15041 cancontinuously generate the magnetic field 15042. The permanent magnet15041 is securely positioned in the surgical instrument such that theorientation and/or magnitude of the magnetic field 15042 does notchange. The wire coil 15043 comprises a copper, or copper alloy, wirewrapped around the outside surface 15023 of the shaft 15020; however,the wire coil 15043 can be comprised of any suitable conductivematerial, such as aluminum, for example. The wire coil 15043 can bewrapped around the shaft 15020 any suitable number of times. Moreover,the wire coil 15043 can be positioned on the shaft 15020 at a locationin which the intensity of the magnetic field 15042 is high, or at itshighest. In at least one instance, the wire coil 15043 can be wrappedaround the shaft 15020 such that the wire coil 15043 is aligned, or atleast substantially aligned, with a polar axis of the magnetic field15042. Generally, the current that is generated within the wire coil15043 is directly proportional to the number of times that the wire coil15043 is wound around the shaft 15020. Moreover, the current that isgenerated within the wire coil 15043 is directly proportional to thespeed in which the shaft 15020 is rotated.

As discussed above, the magnet 15041 can comprise an electromagnet. Theelectromagnet 15041 can be powered by a battery of the surgicalinstrument, for example, to generate the magnetic field 15042. Theelectromagnet 15041 can be selectively activated, or energized, toselectively generate the magnetic field 15042. For instance, theelectromagnet 15041 can be energized only when the shaft 15020 is beingrotated by the motor 15010. In such instances, the electromagnet 15041will not be energized when the shaft 15020 is not rotating. Suchinstances may be useful when prolonged pauses in the operation of theshaft 15020 are anticipated or are in the process of occurring. In atleast one instance, the electromagnet 15041 may be energized prior toshaft 15020 being rotated by the motor 15010. In certain instances, theelectromagnet 15041 may be de-energized after the shaft 15020 hasstopped rotating. Such approaches can assure that the motion of theshaft 15020 can be fully utilized to induce current within the wire coil15043. In various instances, the electromagnet 15041 may be energizedwhether or not the shaft 15020 is rotating. Such instances may be usefulwhen only short pauses in the operation of the shaft 15020 areanticipated or are in the process of occurring.

When the shaft 15020 is not rotating, further to the above, the magneticfield 15042 does not induce a current within the wire coil 15043 and, asa result, the control system 15040, the sensor 15050, and thetransmitter 15060 are not being powered by the magnetic field 15042. Inat least one such instance, the microprocessor 15047 can enter into asleep mode. When the motor 15010 begins to rotate the shaft 15020, thewire coil 15043 is rotated within the magnetic field 15042 and a currentis generated within the wire coil 15043. The wire coil 15043 can be inelectrical communication with an input gate in the microprocessor 15047and can apply a voltage potential to the input gate which can, one,power the microprocessor 15047 and, two, cause the microprocessor 15047to awaken from its sleep mode. In such an embodiment, as a result, thecontrol system 15040 can be in a sleep mode when the shaft 15020 is notrotating and an active, or fully-powered, operating mode when the shaft15020 is rotating.

In various instances, the control system 15040 can include and/or canhave access to a power source when the shaft 15020 is not rotating. Insuch instances, the microprocessor 15047 can enter a low-power mode. Inat least one instance, the control system 15040 can include one or morecapacitive elements, such as supercapacitors, for example, that can beconfigured to store electrical power when the shaft 15020 is beingrotated and current from the wire coil 15043 is being supplied to thecontrol system 15040. When the shaft 15020 is no longer rotating andcurrent from the wire coil 15043 is no longer being supplied to thecontrol circuit 15040, the capacitive elements can supply electricalpower to the microprocessor 15047, and/or any other portion of thecontrol system 15040, and prevent the microprocessor 15047, and/orcontrol system 15040, from entering into a completely unpowered state,at least for a period of time. Such capacitive elements could alsorelease power to the microprocessor 15047, and/or any other portion ofthe control system 15040, the strain gauge 15050, and/or the transmitter15060 when the shaft 15020 is rotating at a slow speed, i.e., a speedwhich is insufficient to generate the power necessary to operate suchcomponents in their fully-powered operating mode. In addition to or inlieu of the above, a battery mounted to the shaft 15020 can supply powerto the microprocessor 15047, and/or any other portion of the controlsystem 15040, the strain gauge 15050, and/or the wireless transmitter15060 when the shaft 15020 is not rotating. Such a battery could alsoprovide power to the microprocessor 15047, and/or any other portion ofthe control system 15040, the strain gauge 15050, and/or the transmitter15060 when the shaft 15020 is rotating slowly and/or when suchcomponents are otherwise underpowered, for example.

Further to the above, the shaft 15020 may be stopped for a multitude ofreasons. For instance, the user of the surgical instrument may choose topause or stop the advancement of a firing member to assess whether thefiring stroke of the firing member could or should be completed and, insuch circumstances, the shaft 15020, which advances the firing member,may be paused or stopped. As discussed above, a current is not inducedin the wire coil 15043 when the shaft 15020 is not rotating; however, itmay be desirable to power the control system 15040, the sensor 15050,and/or the transmitter 15060 in order to collect, evaluate, and/ortransmit data from the sensor 15050 while the shaft 15020 is not beingrotated. A secondary power source described above is capable offacilitating such an operating state of the surgical instrument. In atleast one alternative embodiment, a current can be induced in the wirecoil 15043 even though the shaft 15020 is not rotating. For instance, aplurality of electromagnets 15041 can be positioned around the wire coil15043 which can be selectively energized to create a rotating magneticfield 15042. In such an embodiment, the magnetic field 15042 can berotated relative to the wire coil 15043 to induce a current in the wirecoil 15043 and power the control system 15040, the sensor 15050, and/orthe transmitter 15060 even though the shaft 15020 has been stopped.

In use, further to the above, a power source, such as a battery, forexample, can be utilized to power the electric motor 15010 and rotatethe shaft 15020. As described above, the rotation of the wire coil 15043within a magnetic field 15042 generates a current within the wire coil15043 which supplies power to the control circuit 15040, the sensor15050, and/or the transmitter 15060 positioned on the shaft 15020. Insuch instances, this on-board shaft system re-captures a portion of theenergy expended to rotate the shaft 15020 and utilizes that energy tosense, evaluate, and/or monitor the performance of the shaft 15020.

Various examples disclosed herein have been discussed in connection withthe motor shaft 15020; however, such examples could be applied to anyrotatable shaft and/or rotatable system, such as the shaft 15032, forexample. Moreover, the examples disclosed herein could be applied to therotatable shaft and/or rotatable system of any suitable surgicalinstrument. For instance, the examples disclosed herein could be appliedto a robotic system, such as the DAVINCI robotic surgical systemmanufactured by Intuitive Surgical, Inc., for example. The entiredisclosure of U.S. patent application Ser. No. 13/118,241, entitledSURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENTARRANGEMENTS, now U.S. Pat. No. 9,072,535, is incorporated by referenceherein. The examples disclosed herein could also be applied tonon-surgical applications, such as the crankshaft and/or camshaft of amotor, for example.

A portion of a surgical stapling instrument 16000 is illustrated inFIGS. 134-139. The stapling instrument 16000 is usable with amanually-operated system and/or a robotically-controlled system, forexample. The stapling instrument 16000 comprises a shaft 16010 and anend effector 16020 extending from the shaft 16010. The end effector16020 comprises a cartridge channel 16030 and a staple cartridge 16050positioned in the cartridge channel 16030. Referring primarily to FIGS.137 and 138, the staple cartridge 16050 comprises a cartridge body 16051and a retainer 16057 attached to the cartridge body 16051. The cartridgebody 16051 is comprised of a plastic material, for example, and theretainer 16057 is comprised of metal, for example; however, thecartridge body 16051 and the retainer 16057 can be comprised of anysuitable material. The cartridge body 16051 comprises a deck 16052configured to support tissue, a longitudinal slot 16056, and a pluralityof staple cavities 16053 defined in the deck 16052. Referring primarilyto FIGS. 135 and 136, staples 16055 are removably positioned in thestaple cavities 16053 and are supported by staple drivers 16054 whichare also movably positioned in the staple cavities 16053. The retainer16057 extends around the bottom of the cartridge body 16051 to keep thestaple drivers 16054 and/or the staples 16055 from falling out of thebottom of the staple cavities 16053. The staple drivers 16054 and thestaples 16055 are movable between an unfired position (FIG. 135) and afired position by a sled 16060. The sled 16060 is movable between aproximal, unfired position (FIG. 135) toward a distal, fired position toeject the staples 16055 from the staple cartridge 16050, as illustratedin FIG. 136. The sled 16060 comprises one or more ramped surfaces 16064which are configured to slide under the staple drivers 16054. The endeffector 16020 further comprises an anvil 16040 configured to deform thestaples 16055 when the staples 16055 are ejected from the staplecartridge 16050. In various instances, the anvil 16040 can compriseforming pockets 16045 defined therein which are configured to deform thestaples 16055.

The shaft 16010 comprises a frame 16012 and an outer sleeve 16014 whichis movable relative to the frame 16012. The cartridge channel 16030 ismounted to and extends from the shaft frame 16012. The outer sleeve16014 is operably engaged with the anvil 16040 and is configured to movethe anvil 16040 between an open position (FIG. 134) and a closedposition (FIG. 135). In use, the anvil 16040 is movable toward a staplecartridge 16050 positioned in the cartridge channel 16030 to clamptissue against the deck 16052 of the staple cartridge 16050. In variousalternative embodiments, the cartridge channel 16030 and the staplecartridge 16050 are movable relative to the anvil 16040 to clamp tissuetherebetween. In either event, the shaft 16010 further comprises afiring member 16070 configured to push the sled 16060 distally. Thefiring member 16070 comprises a knife edge 16076 which is movable withinthe longitudinal slot 16056 and is configured to incise the tissuepositioned intermediate the anvil 16040 and the staple cartridge 16050as the firing member 16070 is advanced distally to eject the staples16055 from the staple cartridge 16050. The firing member 16070 furthercomprises a first cam 16071 configured to engage the cartridge channel16030 and a second cam 16079 configured to engage the anvil 16040 andhold the anvil 16040 in position relative to the staple cartridge 16050.The first cam 16071 is configured to slide under the cartridge channel16030 and the second cam 16079 is configured to slide within an elongateslot 16049 defined in the anvil 16040.

Further to the above, the staple cartridge 16050 is a replaceable staplecartridge. When a staple cartridge 16050 has been at least partiallyused, it can be removed from the cartridge channel 16030 and replacedwith another staple cartridge 16050, or any other suitable staplecartridge. Each new staple cartridge 16050 comprises a cartridge body16051, staple drivers 16054, staples 16055, and a sled 16060. The firingmember 16070 is part of the shaft 16010. When a staple cartridge 16050is removed from the cartridge channel 16030, the firing member 16070remains with the shaft 16010. That said, the shaft 16010 itself may bereplaceable as well; however, such a replacement shaft 16010 could stillbe used in the manner described herein. In at least one such instance,the surgical instrument system 16000 could comprise a handle, a shaft16010 replaceably attached to the handle, and a staple cartridge 16050replaceably positioned in the cartridge channel 16030 extending from theshaft 16010, for example. FIG. 137 depicts a staple cartridge 16050positioned over an opening 16031 defined in the cartridge channel 16030and FIG. 138 depicts the staple cartridge 16050 fully seated in thecartridge channel 16030; however, it should be appreciated that severalcomponents of the end effector 16020, such as the anvil 16040, forexample, and the firing member 16070 have been removed from FIGS. 137and 138 to demonstrate the general premise of a staple cartridge 16050being inserted into the cartridge channel 16030. It should beappreciated, however, that a staple cartridge 16050 is often insertedinto the cartridge channel 16030 through the distal end 16038 of thechannel 16030. In such instances, the proximal end 16059 of the staplecartridge 16050 is aligned with the distal end 16038 of the cartridgechannel 16030 and the staple cartridge 16050 is then moved proximally toalign the proximal end 16059 of the staple cartridge 16050 with theproximal end 16039 of the cartridge channel 16030 and, correspondingly,align the distal end 16058 of the staple cartridge 16050 with the distalend 16038 of the cartridge channel 16030. The cartridge channel 16030comprises a datum 16033 configured to stop the proximal insertion of thestaple cartridge 16050. More particularly, the cartridge body 16051comprises a datum shoulder 16034 defined thereon configured to abut thedatum 16033 when the staple cartridge 16050 has been inserted to theproper depth; however, it is possible for the staple cartridge 16050 tobe inserted into the cartridge channel 16030 in a number of ways whichcan prevent the datum shoulder 16034 from contacting the datum 16033.

Regardless of the manner used to position a staple cartridge 16050 inthe cartridge channel 16030, it is desired to position the sled 16060 ofthe staple cartridge 16050 directly in front of the firing member 16070when the staple cartridge 16050 is positioned in the cartridge channel16030. When the sled 16060 is positioned directly in front of the firingmember 16070, the sled 16060 can keep the firing member 16070 fromfalling into a lockout when the firing member 16070 is advanceddistally. More specifically, referring to FIG. 135, the sled 16060includes a support shoulder 16067 which is configured to support asupport tab 16077 extending distally from the firing member 16070 andhold a lock shoulder 16078 of the firing member 16070 above a lockoutwindow 16037 (FIG. 137) defined in the cartridge channel 16030. If thesled 16060 has been advanced distally prior to the staple cartridge16050 being fully seated in the cartridge channel 16030, as illustratedin FIG. 136, the support tab 16077 of the firing member 16070 will notbe supported, or supportable, by the support shoulder 16067 of the sled16060 and, as a result, the lock shoulder 16078 of the firing member16070 will enter the lockout window 16037 when the firing member 16070is advanced distally. In fact, the shaft 16010 includes a biasing spring16018 resiliently engaged with a top surface 16072 of the firing member16070 which biases the firing member 16070 toward the lockout window16037. The entire disclosures of U.S. Pat. No. 7,143,923, entitledSURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSEDANVIL, which issued on Dec. 5, 2006; U.S. Pat. No. 7,044,352, SURGICALSTAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OFFIRING, which issued on May 16, 2006; U.S. Pat. No. 7,000,818, SURGICALSTAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS,which issued on Feb. 21, 2006; U.S. Pat. No. 6,988,649, SURGICALSTAPLING INSTRUMENT HAVING A SPENT CARTRIDGE LOCKOUT, which issued onJan. 24, 2006; and U.S. Pat. No. 6,978,921, SURGICAL STAPLING INSTRUMENTINCORPORATING AN E-BEAM FIRING MECHANISM, which issued on Dec. 27, 2005,are incorporated by reference herein. The above being said, it may bedifficult for the clinician inserting the staple cartridge 16050 intothe cartridge channel 16030 to determine whether the sled 16060 has beenaccidentally, or prematurely, pushed forward prior to inserting, and/orduring the insertion of, the staple cartridge 16050 into the cartridgechannel 16030. As described in detail further below, the surgicalinstrument system 16000 comprises means for assessing whether the sled16060 has been prematurely advanced when the staple cartridge 16050 ispositioned in the cartridge channel 16030.

When moving a staple cartridge 16050 proximally to insert the staplecartridge 16050 in the cartridge channel 16030, as described above, thesled 16060 can be accidentally or unintentionally bumped and pusheddistally from its unfired position (FIG. 135) to a partially-firedposition (FIG. 136). More particularly, referring now to FIG. 139, thesled 16060 in the staple cartridge 16050 can contact the firing member16070 in the shaft 16010 in the event that the staple cartridge 16050 ismis-inserted into the cartridge channel 16030, i.e., inserted too farproximally into the cartridge channel 16030, which can move the sled16060 distally a distance X. Even though the clinician may subsequentlyplace the staple cartridge 16050 in its proper position in the cartridgechannel 16030, the sled 16060 will have already been pushed out of itsproper position in the staple cartridge 16050 and, as a result, thefiring member 16070 will enter the lockout when the firing member 16070is advanced distally. Accordingly, the surgical instrument system 16000will be unable to fire the staple cartridge 16050. Turning now to FIG.140, the surgical instrument system 16000 comprises a mis-insertionsensor 16090 configured to detect when a staple cartridge 16050 has beenover-inserted, or moved too far proximally within the end effector16020, at some point during the process of inserting the staplecartridge 16050 into the cartridge channel 16030.

Further to the above, the mis-insertion sensor 16090 is in signalcommunication with a control system of the surgical instrument system16000. The control system can include a microprocessor and themis-insertion sensor 16090 can be in signal communication with themicroprocessor via at least one signal wire 16092 and/or a wirelesssignal transmitter and receiver system, for example. The mis-insertionsensor 16090 can comprise any suitable sensor. In at least one instance,the mis-insertion sensor 16090 can comprise a contact switch which is inan open condition when a staple cartridge 16050 is not in contact withthe sensor 16090 and a closed condition when a staple cartridge 16050 isin contact with the sensor 16090. The mis-insertion sensor 16090 ispositioned in the cartridge channel 16030 such that, if the staplecartridge 16050 is inserted properly in the cartridge channel 16030, thestaple cartridge 16050 will not contact the mis-insertion sensor 16090.In various instances, the control system of the surgical instrumentsystem 16000 can include an indicator which can indicate to the user ofthe surgical instrument system 16000 that the mis-insertion sensor 16090and the microprocessor have not detected a mis-insertion of a staplecartridge 16050.

In the event that the staple cartridge 16050 is over-inserted into thecartridge channel 16030 and the staple cartridge 16050 contacts themis-insertion sensor 16090, further to the above, the microprocessor candetect the closure of the sensor 16090 and take an appropriate action.Such an appropriate action may include warning the user of the surgicalinstrument system 16000 that the staple cartridge 16050 has beenover-inserted and that the sled 16060 of the staple cartridge 16050 mayhave been moved distally pre-maturely. In at least one instance, thesurgical instrument system 16000 can include an indicator which, whenilluminated, can indicate to the user that the condition of the staplecartridge 16050 positioned in the cartridge channel 16030 is unreliableand that it should be removed and replaced with another staple cartridge16050. In addition to or in lieu of the above, the surgical instrumentsystem 16000 can include a display screen, for example, which couldcommunicate this information to the user of the surgical instrumentsystem 16000. In addition to or in lieu of the above, the microprocessorcan deactivate the closure system of the surgical instrument system16000 to prevent the anvil 16040 from being moved into a closed positionwhen the microprocessor has determined that a staple cartridge 16050 hasbeen over-inserted into the cartridge channel 16030 and/or that thecondition of the staple cartridge 16050 positioned in the cartridgechannel 16030 is unreliable. By preventing the anvil 16040 from closing,in the embodiments where the surgical instrument system 16000 comprisesan endoscopic surgical stapler, for example, the end effector 16020 ofthe surgical instrument system 16000 cannot be inserted through a trocarinto a patient and, thus, the surgical instrument system 16000 canrequire the user to replace the staple cartridge 16050 before thesurgical instrument 16000 can be used.

When the mis-insertion sensor 16090 comprises a contact switch, furtherto the above, the sensor 16090 can be positioned in any suitablelocation in the cartridge channel 16030 in which a staple cartridge16050 would make contact with the sensor 16090 if the staple cartridge16050 is mis-inserted. As illustrated in FIG. 140, the mis-insertionsensor 16090 can be positioned on either side of a longitudinal slot16036 extending through the cartridge channel 16030, for example. Asdiscussed above, however, the mis-insertion sensor 16090 can compriseany suitable type of sensor and, as a result, the sensor 16090 can bepositioned in any suitable position in the end effector 16020 and/orshaft 16010, depending on the type of sensor that is being used. Forinstance, the mis-insertion sensor 16090 can comprise a Hall Effectsensor, for example, which can emit a magnetic field and detect changesto that magnetic field when the staple cartridge 16050 is inserted intothe cartridge channel 16030. In various instances, a large disturbanceto the magnetic field can indicate that the staple cartridge 16050 isclose to the sensor 16090. If the disturbance to the magnetic fieldexceeds a threshold level, then the microprocessor can determine thatthe staple cartridge 16050 was positioned too close to the sensor 16090during the insertion of the staple cartridge 16050 into the cartridgechannel 16030 and, as a result, the staple cartridge 16050 has beenover-inserted into the cartridge channel 16030 at some point. In atleast one instance, the cartridge body 16051, the retainer 16057, and/orthe sled 16060 can include one or more magnetic elements which can beconfigured to disturb the magnetic field of the sensor 16090, forexample.

In addition to or in lieu of the above, referring now to FIGS. 141 and142, the surgical instrument system 16000 can comprise a sensor 16080configured to directly detect whether the sled 16060 is in its correct,or unfired, position when the staple cartridge 16050 is positioned inthe cartridge channel 16030. The sensor 16080 is positioned in a recess16032 defined in the cartridge channel 16030; however, the sensor 16080can be positioned in any suitable location. The sensor 16080 is alignedwith the proximal end of the sled 16060 when the sled 16060 is in itsunfired position, as illustrated in FIG. 141. In such instances, thesled 16060 is positioned over the sensor 16080 and is in contact withthe sensor 16080. The sensor 16080 comprises a contact switch which isin a closed condition when the sled 16060 is engaged with the sensor16080, for example. In various instances, the sensor 16080 can comprisea continuity sensor, for example. When the sled 16060 is advanceddistally, the sled 16060 is no longer aligned with or in contact withthe sensor 16080. In such instances, the contact switch of the sensor16080 is in an open condition. The sensor 16080 is in signalcommunication with the microprocessor of the control system of thesurgical instrument system 16000 via at least one signal wire 16082and/or a wireless signal transmitter and receiver system, for example.When a staple cartridge 16050 is inserted into the channel, the sensor16080 and the microprocessor can evaluate whether the sled 16060 is inits unfired position and, if it is not, take an appropriate action, suchas the appropriate actions discussed above, for example.

Referring now to FIG. 143, the sensor 16080 comprises a first contact16084 and a second contact 16085. The second contact 16085 comprises afree end positioned over the first contact 16084 which is movablebetween an open position in which a gap 16086 is present between thesecond contact 16085 and the first contact 16084 and a closed positionin which the second contact 16085 is deflected into contact with thefirst contact 16084. The first contact 16084 and the second contact16085 are comprised of an electrically conductive material, such ascopper, for example, and, when the second contact 16085 is in contactwith the first contact 16084, the sensor 16080 closes a circuit whichpermits current to flow therethrough. The sensor 16080 further comprisesa flexible housing 16083 which surrounds the ends of the first contact16084 and the second contact 16085. The housing 16083 comprises a sealeddeformable membrane; however, any suitable configuration could be used.The housing 16083 is comprised of an electrically insulative material,such as plastic, for example. When the sled 16060 contacts the sensor16080, as discussed above, the sled 16060 can push the housing 16083downwardly and deflect the second contact 16085 toward the first contact16084 to close the sensor 16080. If the sled 16060 has been advanceddistally prior to the staple cartridge 16050 being fully seated in thecartridge channel 16030, the sled 16060 will not deflect the housing16083 and the second contact 16085 downwardly. As a result of the above,the sensor 16080 can not only detect whether a staple cartridge 16050 ispresent in the cartridge channel 16030, but it can also detect whetherthe staple cartridge 16050 has been at least partially fired.

In addition to or in lieu of the above, the sensor 16080 can compriseany suitable sensor, such as a Hall Effect sensor, for example, which isconfigured to emit a magnetic field and detect changes to the magneticfield. The sled 16060 can include a magnetic element mounted thereto,such as on the bottom of the sled 16060, for example, and, when thestaple cartridge 16050 is positioned in the cartridge channel 16030, themagnetic element can disrupt the magnetic field emitted by the sensor16080. The sensor 16080 and the microprocessor of the surgicalinstrument control system can be configured to evaluate the magnitude inwhich the magnetic field has been disrupted and correlate the disruptionof the magnetic field with the position of the sled 16060. Such anarrangement may be able to determine whether the sled 16060 is in anacceptable range of positions. For instance, the microprocessor mayassess whether the disturbance of the magnetic field has exceeded athreshold and, if it has, the microprocessor can indicate to the userthat the staple cartridge 16050 is suitable for use and, if thethreshold has not been exceeded, the microprocessor can take a suitableaction, as described above.

In addition to or in lieu of assessing whether a staple cartridge hasbeen inserted to its proper depth in the cartridge channel 16030, thesensor 16080 can be configured to assess whether a staple cartridge16050 has been fully seated in the cartridge channel 16030. Forinstance, referring again to FIG. 143, the sled 16060 may deflect thesecond contact 16085 enough to contact the first contact 16084 only whenthe staple cartridge 16050 is fully seated in the staple channel 16030.When the sensor 16080 comprises a Hall Effect sensor, for example, thethreshold disturbance that the sled 16060 must create to indicate thatthe staple cartridge 16050 is suitable for use may not only require thatthe staple cartridge 16050 be inserted to its proper depth in thecartridge channel 16030 and that the sled 16060 be in its unfiredposition but it may also require that the staple cartridge 16050 be inits fully seated condition. Referring now to FIG. 144, an alternativesensor 16080′ is depicted which comprises a pressure sensitive switch.The sensor 16080′ comprises a variable resistive element 16086′positioned intermediate the first contact 16084 and the second contact16085. In at least one instance, the variable resistive element 16086′can comprise a semi-conductive spacer, for example. The resistance ofthe variable resistive element 16086′ is a function of the pressure, orforce, being applied to it. For instance, if a low pressure is appliedto the variable resistive element 16086′ then the variable resistiveelement 16086′ will have a low resistance and, correspondingly, if ahigh pressure is applied to the resistive element 16086′ then theresistive element 16086′ will have a high resistance. The microprocessorcan be configured to correlate the resistance of the resistive element16086′ with the pressure being applied to the sensor 16080′ and,ultimately, correlate the pressure being applied to the sensor 16080′with the height in which the staple cartridge 16050 is seated in thecartridge channel 16030. Once the resistance of the resistive element16086′ has exceeded a threshold resistance, the microprocessor candetermine that the staple cartridge 16050 is ready to be fired. If,however, the resistance of the resistive element 16086′ is below thethreshold resistance, the microprocessor can determine that the staplecartridge 16050 has not been fully seated in the cartridge channel 16030and take an appropriate action.

The present disclosure will now be described in connection with variousexamples and various combinations of such examples as describedhereinbelow.

1. One example provides an electronic system for a surgical instrument,the electronic system comprising: an electric motor coupled to the endeffector; a motor controller coupled to the motor; a parameter thresholddetection module configured to monitor multiple parameter thresholds; asensing module configured to sense tissue compression; a processorcoupled to the parameter threshold detection module and the motorcontroller; and a memory coupled to the processor, the memory storingexecutable instructions that when executed by the processor cause theprocessor to monitor multiple levels of action thresholds and monitorspeed of the motor and increment a drive unit of the motor, sense tissuecompression, and provide rate and control feedback to the user of thesurgical instrument.

2. Another example provides the electronic system of example 1, whereinthe processor provides automatic compensation for motor load whenthresholds detected by the parameter threshold detection module arewithin acceptable limits.

3. Another example provides the electronic system of example 1 or 2,wherein the parameter threshold detection module is configured to detectbattery current and speed of the motor such that when the batterycurrent increases or the speed of the motor decreases the motorcontroller increase a pulse width or frequency modulation to maintainthe speed of the motor constant.

4. Another example provides the electronic system of any one of examples1-3, wherein the parameter threshold detection module is configured todetect minimum and maximum threshold limits to control operation of thesurgical instrument.

5. Another example provides the electronic system of example 4, whereinthe parameter threshold detection module is configured to detect endeffector closing force, end effector opening force, and speed of themotor.

6. Another example provides the electronic system of example 5, whereinwhen the end effector closing force decreases while a knife istranslating through a knife channel in the end effector, the processoris configured to control the speed of the motor.

7. Another example provides the electronic system of example 5 or 6,wherein when the end effector closing force decreases while a knife istranslating through a knife channel, the processor is configured toactivate an alarm.

8. Another example provides the electronic system of any one of examples4-7, wherein the processor is configured to activate the motor onlyafter a minimum parameter threshold is detected.

9. Another example provides the electronic system of any one of examples1-8, wherein the parameter threshold detection module is configured todetect an ultimate threshold associated with current draw, end effectorpressure applied to tissue, firing load, or torque, wherein when theultimate threshold is exceeded, the processor is configured to shut downthe motor or cause the motor to retract the knife.

10. Another example provides the electronic system of example 9, whereinthe parameter threshold detection module is configured to detect asecondary threshold which is less than the ultimate threshold, whereincontrol parameters are changed by the processor to accommodate thechange in operation.

11. Another example provides the electronic system of example 9 or 10,wherein the parameter threshold detection module is configured to detecta marginal threshold in the form of either a step function or rampfunction based on a proportional response to another input to theparameter threshold detection module.

12. Yet another example provides an electronic system for a surgicalinstrument, the electronic system comprising: an electric motor coupledto the end effector; a motor controller coupled to the motor; a sensingmodule configured to sense tissue compression; a processor coupled tothe parameter threshold detection module and the motor controller; and amemory coupled to the processor, the memory storing executableinstructions that when executed by the processor cause the processor tomonitor the sensing module, wherein the sensing module is configured tosense multiple tissue parameters.

13. Another example provides the electronic system of example 12,wherein the sensing module is configured to sense tissue compression.

14. Another example provides the electronic system of example 12 or 13,wherein the sensing module is configured to sense tissue impedance.

15. Another example provides the electronic system of example 14,wherein the sensing module is coupled to electrodes to measure tissueimpedance via sub-therapeutic RF energy.

16. Another example provides the electronic system of example 15,wherein the sensing module is configured to read overlaid multiplefrequency signals to measure impedance in different locationssimultaneously.

17. Another example provides the electronic system of example 15 or 16,wherein the sensing module comprises a multiplexor to measure impedanceat variable RF frequencies sequentially.

18. Another example provides the electronic system of any one ofexamples 12-17, wherein the sensing module is configured to sense tissuepressure.

19. Another example provides the electronic system of any one ofexamples 12-18, wherein the sensing module is configured to sense tissuecontact.

20. Another example provides the electronic system of any one ofexamples 12-19, wherein the sensing module is configured to senseviscoelasticity rate of change.

21. Yet another example provides an electronic system for a surgicalinstrument, the electronic system comprising: an electric motor coupledto the end effector; a motor controller coupled to the motor; a sensingmodule configured to sense tissue compression; a feedback moduleconfigured to provide rate and control feedback to a user of thesurgical instrument; a processor coupled to the parameter thresholddetection module and the motor controller; and a memory coupled to theprocessor, the memory storing executable instructions that when executedby the processor cause the processor to monitor the sensing module,wherein the sensing module is configured to sense multiple tissueparameters and provide feedback over the feedback module to a user ofthe instrument.

In accordance with various examples, the surgical instruments describedherein may comprise one or more processors (e.g., microprocessor,microcontroller) coupled to various sensors. In addition, to theprocessor(s), a storage (having operating logic) and communicationinterface, are coupled to each other.

As described earlier, the sensors may be configured to detect andcollect data associated with the surgical device. The processorprocesses the sensor data received from the sensor(s).

The processor may be configured to execute the operating logic. Theprocessor may be any one of a number of single or multi-core processorsknown in the art. The storage may comprise volatile and non-volatilestorage media configured to store persistent and temporal (working) copyof the operating logic.

In various aspects, the operating logic may be configured to perform theinitial processing, and transmit the data to the computer hosting theapplication to determine and generate instructions. For these examples,the operating logic may be further configured to receive informationfrom and provide feedback to a hosting computer. In alternate examples,the operating logic may be configured to assume a larger role inreceiving information and determining the feedback. In either case,whether determined on its own or responsive to instructions from ahosting computer, the operating logic may be further configured tocontrol and provide feedback to the user.

In various aspects, the operating logic may be implemented ininstructions supported by the instruction set architecture (ISA) of theprocessor, or in higher level languages and compiled into the supportedISA. The operating logic may comprise one or more logic units ormodules. The operating logic may be implemented in an object orientedmanner. The operating logic may be configured to be executed in amulti-tasking and/or multi-thread manner. In other examples, theoperating logic may be implemented in hardware such as a gate array.

In various aspects, the communication interface may be configured tofacilitate communication between a peripheral device and the computingsystem. The communication may include transmission of the collectedbiometric data associated with position, posture, and/or movement dataof the user's body part(s) to a hosting computer, and transmission ofdata associated with the tactile feedback from the host computer to theperipheral device. In various examples, the communication interface maybe a wired or a wireless communication interface. An example of a wiredcommunication interface may include, but is not limited to, a UniversalSerial Bus (USB) interface. An example of a wireless communicationinterface may include, but is not limited to, a Bluetooth interface.

For various aspects, the processor may be packaged together with theoperating logic. In various examples, the processor may be packagedtogether with the operating logic to form a SiP. In various examples,the processor may be integrated on the same die with the operatinglogic. In various examples, the processor may be packaged together withthe operating logic to form a System on Chip (SoC).

Various aspects may be described herein in the general context ofcomputer executable instructions, such as software, program modules,and/or engines being executed by a processor. Generally, software,program modules, and/or engines include any software element arranged toperform particular operations or implement particular abstract datatypes. Software, program modules, and/or engines can include routines,programs, objects, components, data structures and the like that performparticular tasks or implement particular abstract data types. Animplementation of the software, program modules, and/or enginescomponents and techniques may be stored on and/or transmitted acrosssome form of computer-readable media. In this regard, computer-readablemedia can be any available medium or media useable to store informationand accessible by a computing device. Some examples also may bepracticed in distributed computing environments where operations areperformed by one or more remote processing devices that are linkedthrough a communications network. In a distributed computingenvironment, software, program modules, and/or engines may be located inboth local and remote computer storage media including memory storagedevices. A memory such as a random access memory (RAM) or other dynamicstorage device may be employed for storing information and instructionsto be executed by the processor. The memory also may be used for storingtemporary variables or other intermediate information during executionof instructions to be executed by the processor.

Although some aspects may be illustrated and described as comprisingfunctional components, software, engines, and/or modules performingvarious operations, it can be appreciated that such components ormodules may be implemented by one or more hardware components, softwarecomponents, and/or combination thereof. The functional components,software, engines, and/or modules may be implemented, for example, bylogic (e.g., instructions, data, and/or code) to be executed by a logicdevice (e.g., processor). Such logic may be stored internally orexternally to a logic device on one or more types of computer-readablestorage media. In other examples, the functional components such assoftware, engines, and/or modules may be implemented by hardwareelements that may include processors, microprocessors, circuits, circuitelements (e.g., transistors, resistors, capacitors, inductors, and soforth), integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates,registers, semiconductor device, chips, microchips, chip sets, and soforth.

Examples of software, engines, and/or modules may include softwarecomponents, programs, applications, computer programs, applicationprograms, system programs, machine programs, operating system software,middleware, firmware, software modules, routines, subroutines,functions, methods, procedures, software interfaces, application programinterfaces (API), instruction sets, computing code, computer code, codesegments, computer code segments, words, values, symbols, or anycombination thereof. Determining whether one example is implementedusing hardware elements and/or software elements may vary in accordancewith any number of factors, such as desired computational rate, powerlevels, heat tolerances, processing cycle budget, input data rates,output data rates, memory resources, data bus speeds and other design orperformance constraints.

One or more of the modules described herein may comprise one or moreembedded applications implemented as firmware, software, hardware, orany combination thereof. One or more of the modules described herein maycomprise various executable modules such as software, programs, data,drivers, application APIs, and so forth. The firmware may be stored in amemory of the controller and/or the controller which may comprise anonvolatile memory (NVM), such as in bit-masked ROM or flash memory. Invarious implementations, storing the firmware in ROM may preserve flashmemory. The NVM may comprise other types of memory including, forexample, programmable ROM (PROM), erasable programmable ROM (EPROM),EEPROM, or battery backed RAM such as dynamic RAM (DRAM),Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).

In some cases, various aspects may be implemented as an article ofmanufacture. The article of manufacture may include a computer readablestorage medium arranged to store logic, instructions and/or data forperforming various operations of one or more examples. In variousexamples, for example, the article of manufacture may comprise amagnetic disk, optical disk, flash memory or firmware containingcomputer program instructions suitable for execution by a generalpurpose processor or application specific processor. The examples,however, are not limited in this context.

The functions of the various functional elements, logical blocks,modules, and circuits elements described in connection with the examplesdisclosed herein may be implemented in the general context of computerexecutable instructions, such as software, control modules, logic,and/or logic modules executed by the processing unit. Generally,software, control modules, logic, and/or logic modules comprise anysoftware element arranged to perform particular operations. Software,control modules, logic, and/or logic modules can comprise routines,programs, objects, components, data structures and the like that performparticular tasks or implement particular abstract data types. Animplementation of the software, control modules, logic, and/or logicmodules and techniques may be stored on and/or transmitted across someform of computer-readable media. In this regard, computer-readable mediacan be any available medium or media useable to store information andaccessible by a computing device. Some examples also may be practiced indistributed computing environments where operations are performed by oneor more remote processing devices that are linked through acommunications network. In a distributed computing environment,software, control modules, logic, and/or logic modules may be located inboth local and remote computer storage media including memory storagedevices.

Additionally, it is to be appreciated that the aspects described hereinillustrate example implementations, and that the functional elements,logical blocks, modules, and circuits elements may be implemented invarious other ways which are consistent with the described examples.Furthermore, the operations performed by such functional elements,logical blocks, modules, and circuits elements may be combined and/orseparated for a given implementation and may be performed by a greaternumber or fewer number of components or modules. As will be apparent tothose of skill in the art upon reading the present disclosure, each ofthe individual examples described and illustrated herein has discretecomponents and features which may be readily separated from or combinedwith the features of any of the other several aspects without departingfrom the scope of the present disclosure. Any recited method can becarried out in the order of events recited or in any other order whichis logically possible.

It is worthy to note that any reference to “one example” or “an example”means that a particular feature, structure, or characteristic describedin connection with the example is comprised in at least one example. Theappearances of the phrase “in one example” or “in one aspect” in thespecification are not necessarily all referring to the same example.

Unless specifically stated otherwise, it may be appreciated that termssuch as “processing,” “computing,” “calculating,” “determining,” or thelike, refer to the action and/or processes of a computer or computingsystem, or similar electronic computing device, such as a generalpurpose processor, a DSP, ASIC, FPGA or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described hereinthat manipulates and/or transforms data represented as physicalquantities (e.g., electronic) within registers and/or memories intoother data similarly represented as physical quantities within thememories, registers or other such information storage, transmission ordisplay devices.

It is worthy to note that some aspects may be described using theexpression “coupled” and “connected” along with their derivatives. Theseterms are not intended as synonyms for each other. For example, someaspects may be described using the terms “connected” and/or “coupled” toindicate that two or more elements are in direct physical or electricalcontact with each other. The term “coupled,” however, also may mean thattwo or more elements are not in direct contact with each other, but yetstill co-operate or interact with each other. With respect to softwareelements, for example, the term “coupled” may refer to interfaces,message interfaces, API, exchanging messages, and so forth.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

The present disclosure applies to conventional endoscopic and opensurgical instrumentation as well as application in robotic-assistedsurgery.

Aspects of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Examples may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, examples of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, examples of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, aspects described herein may be processed beforesurgery. First, a new or used instrument may be obtained and whennecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device also may be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, plasma peroxide, or steam.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely examples and that in fact many other architectures may beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically matable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

Some aspects may be described using the expression “coupled” and“connected” along with their derivatives. It should be understood thatthese terms are not intended as synonyms for each other. For example,some aspects may be described using the term “connected” to indicatethat two or more elements are in direct physical or electrical contactwith each other. In another example, some aspects may be described usingthe term “coupled” to indicate that two or more elements are in directphysical or electrical contact. The term “coupled,” however, also maymean that two or more elements are not in direct contact with eachother, but yet still co-operate or interact with each other.

In some instances, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Thoseskilled in the art will recognize that “configured to” can generallyencompass active-state components and/or inactive-state componentsand/or standby-state components, unless context requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from the subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true scope of the subject matter described herein. It will beunderstood by those within the art that, in general, terms used herein,and especially in the appended claims (e.g., bodies of the appendedclaims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that when aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even when a specific number of an introduced claimrecitation is explicitly recited, those skilled in the art willrecognize that such recitation should typically be interpreted to meanat least the recited number (e.g., the bare recitation of “tworecitations,” without other modifiers, typically means at least tworecitations, or two or more recitations). Furthermore, in thoseinstances where a convention analogous to “at least one of A, B, and C,etc.” is used, in general such a construction is intended in the senseone having skill in the art would understand the convention (e.g., “asystem having at least one of A, B, and C” would include but not belimited to systems that have A alone, B alone, C alone, A and Btogether, A and C together, B and C together, and/or A, B, and Ctogether, etc.). In those instances where a convention analogous to “atleast one of A, B, or C, etc.” is used, in general such a constructionis intended in the sense one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, or C” wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). It will be further understood by those withinthe art that typically a disjunctive word and/or phrase presenting twoor more alternative terms, whether in the description, claims, ordrawings, should be understood to contemplate the possibilities ofincluding one of the terms, either of the terms, or both terms unlesscontext dictates otherwise. For example, the phrase “A or B” will betypically understood to include the possibilities of “A” or “B” or “Aand B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flows are presented in asequence(s), it should be understood that the various operations may beperformed in other orders than those which are illustrated, or may beperformed concurrently. Examples of such alternate orderings may includeoverlapping, interleaved, interrupted, reordered, incremental,preparatory, supplemental, simultaneous, reverse, or other variantorderings, unless context dictates otherwise. Furthermore, terms like“responsive to,” “related to,” or other past-tense adjectives aregenerally not intended to exclude such variants, unless context dictatesotherwise.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing disclosure hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or limiting to the precise form disclosed.Modifications or variations are possible in light of the aboveteachings. The one or more examples were chosen and described in orderto illustrate principles and practical application to thereby enable oneof ordinary skill in the art to utilize the various examples and withvarious modifications as are suited to the particular use contemplated.It is intended that the claims submitted herewith define the overallscope.

1-20. (canceled)
 21. A surgical instrument, comprising: a handle, comprising: a battery; and a motor configured to output a rotary motion when supplied with power from said battery; a shaft extending from said handle; an end effector extending from said shaft, wherein said end effector comprises: an anvil; and a staple cartridge comprising a plurality of staples removably stored therein; a firing member configured to advance through said end effector during a firing stroke in response to said rotary motion; a microcontroller in signal communication with said motor, wherein said microcontroller comprises a processor; an electrical load sensor configured to measure the force on said firing member during said firing stroke, wherein said electrical load sensor is configured to communicate the measured force to said processor; and a feedback display in signal communication with said processor, wherein said feedback display comprises a plurality of zones indicative of the measured force on said firing member, and wherein said plurality of zones comprises: a first zone which indicates the firing member is being advanced in a first operating state; a second zone which indicates the firing member is being advanced in a second operating state, wherein said second operating state is different than said first operating state; and a third zone which indicates the firing member is being advanced in a third operating state, wherein said third operating state is different than said first operating state and said second operating state.
 22. The surgical instrument of claim 21, wherein said feedback display further comprises a pointer and an arcuate shaped dial, and wherein said first zone, said second zone, and said third zone are defined within said arcuate shaped dial.
 23. A surgical instrument, comprising: a handle, comprising: a battery; and a motor configured to output a rotary motion when supplied with power from said battery; a shaft extending from said handle; an end effector extending from said shaft, wherein said end effector comprises: an anvil; and a staple cartridge comprising a plurality of staples removably stored therein; a firing member configured to advance through said end effector during a firing stroke in response to said rotary motion; a microcontroller in signal communication with said motor, wherein said microcontroller comprises a processor; a current sensor configured to measure the current draw of said motor during said firing stroke, wherein said current sensor is configured to communicate the measured current draw to said processor; and a feedback display in signal communication with said processor, wherein said feedback display comprises a plurality of zones indicative of the measured current received by said processor from said current sensor, and wherein said plurality of zones comprises: a first zone which indicates the firing member is being advanced at a first rate; a second zone which indicates the firing member is being advanced at a second rate, wherein said second rate is different than said first rate; and a third zone which indicates the firing member is being advanced at a third rate, wherein said third rate is different than said first rate and said second rate.
 24. The surgical instrument of claim 23, wherein said feedback display further comprises a pointer and an arcuate shaped dial, and wherein said first zone, said second zone, and said third zone are defined within said arcuate shaped dial. 